Selected Abstracts from GDPA Pearls Conference 2025

J Clin Aesthet Dermatol. 2025;18(11–12 Suppl 1):S14–S22.

September 3–6, 2025 in Alpharetta, Georgia

Acne

Early and sustained effects of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel

Presenters: Leon H. Kircik, MD;¹ Edward (Ted) Lain, MD, MBA;² Hilary Baldwin, MD;³ Linda Stein Gold, MD;⁴ Joshua A. Zeichner, MD;¹ Karol Wroblewski, PharmD;⁵ Eric Guenin, PharmD, PhD, MPH;⁶ Michael Gold, MD;⁷ Valerie D. Callender, MD;⁸ Zoe D. Draelos, MD;⁹ Julie C. Harper, MD¹⁰

Affiliations: ¹Icahn School of Medicine at Mount Sinai, New York, NY; ²Austin Institute for Clinical Research, Austin, TX; ³The Acne Treatment and Research Center, Brooklyn, NY; ⁴Henry Ford Hospital, Detroit, MI; ⁵Rutgers University, New Brunswick, NJ; ⁶Ortho Dermatologics*, Bridgewater, NJ; ⁷Tennessee Clinical Research Center, Nashville, TN; ⁸Howard University College of Medicine, Washington, DC; ⁹Dermatology Consulting Services, PLLC, High Point, NC; ¹⁰Dermatology & Skin Care Center of Birmingham, Birmingham, AL

*Ortho Dermatologics is a division of Bausch Health US, LLC.

Introduction: One of the most effective acne treatments is a combination of a topical antibiotic, retinoid, and benzoyl peroxide (BPO), which has demonstrated greater efficacy versus monotherapy or dyads. However, it is unknown if triple-combinations provide more rapid improvement along with minimal tolerability issues, which might improve patient adherence. Clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% (CAB) gel—the only fixed-dose, triple-combination topical approved for acne—has demonstrated efficacy and favorable tolerability in clinical trials. This pooled analysis evaluated efficacy and safety of CAB gel versus vehicle following four and 12 weeks of treatment.

Methods: Data were pooled from four double-blind, 12-week trials (Phase II, NCT03170388 and NCT04892706; Phase III, NCT04214639 and NCT04214652) of participants aged nine years or older (≥12 years in NCT04892706) with moderate-to-severe acne. Endpoints included change from baseline in inflammatory/noninflammatory lesions and treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 or 1 [clear/almost clear]). Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were assessed.

Results: Data from 1,115 participants (CAB, n=618, vehicle, n=497) were analyzed. Inflammatory lesions were reduced by over 50 percent with CAB at Week 4, with continued reductions of over 75 percent at Week 12, significantly greater than vehicle (Week 4: 53.8% vs. 39.6%, respectively; Week 12: 76.9% vs. 52.9%; p<0.001 both). Similar trends were observed for noninflammatory lesions (p<0.001 both). At Week 12, treatment success was achieved by 51.0 percent of CAB-treated participants versus 18.3 percent with vehicle (p<0.001), with significant differences observed at Week 4 (10.7% vs. 4.2%; p<0.001). The only treatment-related TEAE in five percent or more of CAB-treated participants was application-site pain. By Week 4, transient increases in mean safety/tolerability scores for scaling, erythema, itching, stinging, and burning with CAB generally resolved to at/near baseline levels.

Conclusion: In this pooled analysis, fixed-dose CAB gel demonstrated rapid therapeutic effects as early as Week 4 and was well tolerated. While long-term topical acne treatment is often needed to achieve clear skin, the fast-acting efficacy of the only approved triple-combination product for acne—coupled with its once-daily dosing and tolerability—might positively impact patient satisfaction and treatment adherence.

Funding/financial disclosures: Ortho Dermatologics

Long-term clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel use and assessing Cutibacterium acnes susceptibility: a 6-month open-label analysis

Presenters: Mahmoud Ghannoum,¹ Ahmed Eltokhy,¹ James Sewake,¹ Thomas McCormick,¹ Neal Bhatia,² Matthew J. Bruno,³ Hilary Baldwin,⁴ Linda Stein Gold,⁵ Julie C. Harper,⁶ Joshua A. Zeichner,⁷ Edward (Ted) Lain,⁸ Valerie D. Callender,⁹ Eric Guenin,¹⁰ Zoe D. Draelos¹¹

Affiliations: ¹Case Western Reserve University, School of Medicine, Cleveland, OH; ²Therapeutics Clinical Research, San Diego, CA; ³Dermatology and Skin Cancer Surgery Centers, Allen, TX; ⁴The Acne Treatment and Research Center, Brooklyn, NY; ⁵Henry Ford Hospital, Detroit, MI; ⁶Dermatology & Skin Care Center of Birmingham, Birmingham, AL; ⁷Icahn School of Medicine at Mount Sinai, New York, NY; ⁸Austin Institute for Clinical Research, Austin, TX; ⁹Callender Dermatology and Cosmetic Center, Glenn Dale, MD; ¹⁰Ortho Dermatologics,* Bridgewater, NJ; ¹¹Dermatology Consulting Services, High Point, NC

*Ortho Dermatologics is a division of Bausch Health US, LLC, which is an affiliate of Bausch Health Companies Inc.

Introduction: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved triple-combination acne topical—demonstrated superior efficacy to vehicle, with favorable safety/tolerability in 12-week Phase II and Phase III trials. However, in some real-world cases, acne treatment might require six months for maximum benefits. As long-term antibiotic use can produce antibiotic resistance in the causative bacterium Cutibacterium acnes (C. acnes), this analysis evaluated the impact of long-term CAB gel use on C. acnes populations.

Methods: Data from two identical, 24-week, single-center, open-label studies were pooled to evaluate once-daily CAB gel in participants aged 12 years or older with moderate/severe acne (Investigator’s Global Assessment [IGA] of 3/4). Brucella blood agar plates inoculated with central forehead swabs collected at baseline and Week 24 were monitored for colony formation. C. acnes clindamycin susceptibility was assessed via minimum inhibitory concentration (MIC) values obtained from epsilometer tests, with lower MIC indicating higher susceptibility. Isolates with MIC 8µg/mL or greater were deemed resistant.

Results: Of 50 participants enrolled, 45 completed the studies. At baseline, C. acnes strains were isolated from 82 percent (37/45) of participants; remaining samples produced no bacterial growth. Following 24 weeks of CAB treatment, participants with cultivable isolates were reduced by nearly half to 44 percent (20/45), demonstrating elimination of C. acnes populations. For all susceptible strains isolated at Week 24, MIC values remained low (mean: 0.19µg/mL). Only one participant with no growth at baseline had cultivable C. acnes at Week 24, deemed clindamycin-susceptible. There was no change from baseline in clindamycin-resistant isolates; only the five participants (11%) with resistant C. acnes isolates at baseline also had resistant isolates at study end. Importantly, all five of these participants had improvements in acne at Week 24 (IGA decrease, 1–3 points; lesion reductions, 40%–100%).

Conclusion: In 45 participants who completed these open-label studies, treatment with CAB gel for 24 weeks did not lead to the development of antibiotic resistance and resulted in nearly 50-percent reduction from baseline in participants with cultivable C. acnes isolates. Taken together with previously published efficacy analyses, these data suggest CAB is well suited to long-term acne treatment.

Funding/financial disclosures: Ortho Dermatologics

 

Long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for acne: pooled results from two 6-month studies

Presenters: Zoe D. Draelos, MD;¹ Hilary Baldwin, MD;^2,3 Julie C. Harper, MD;⁴ Matthew J. Bruno, PA-C;⁵ Shanna M. Miranti, MPAS, PA-C;⁶ Mahmoud Ghannoum, PhD;^7,8 Linda Stein Gold, MD;⁹ Emil A. Tanghetti, MD;¹⁰ Eric Guenin, PharmD, PhD, MPH;¹¹ Leon H. Kircik^12,13

Affiliations: ¹Dermatology Consulting Services, High Point, NC; ²The Acne Treatment and Research Center, Brooklyn, NY; ³Robert Wood Johnson University Hospital, New Brunswick, NJ; ⁴Dermatology & Skin Care Center of Birmingham, Birmingham, AL; ⁵Dermatology and Skin Cancer Surgery Centers, Allen, TX; ⁶Riverchase Dermatology, Naples, FL; ⁷Case Western Reserve University, Cleveland, OH; ⁸University Hospitals Cleveland Medical Center, Cleveland, OH; ⁹Henry Ford Hospital, Detroit, MI; ¹⁰Center for Dermatology and Laser Surgery, Sacramento, CA; ¹¹Ortho Dermatologics, Bridgewater, NJ; ¹²Icahn School of Medicine at Mount Sinai, New York, NY; ¹³Indiana University School of Medicine, Indianapolis, IN

*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Introduction: Acne is a chronic condition that might require months to years of treatment in some cases. Even after lesion resolution, sequelae, such as scarring and dyspigmentation, might persist and be more concerning to patients than the acne itself. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved triple-combination acne topical—demonstrated superior efficacy to vehicle and component dyads, with favorable safety/tolerability in 12-week Phase II and Phase III trials. This pooled analysis assessed CAB’s long-term efficacy/tolerability and reductions in acne scarring/dyspigmentation.

Methods: Data were pooled from two identical, 24-week, single-center, open-label studies that assessed once-daily CAB in 50 participants 12 years or older with moderate/severe acne (Investigator’s Global Assessment [IGA] score: 3/4). Endpoints included change from baseline in IGA score and inflammatory/noninflammatory lesions. Investigator-assessed skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]) and participant-assessed tolerability (itching, burning, redness, swelling) were evaluated on a five-point scale (0 [none] to 4 [severe]). Scarring was assessed using the Goodman Qualitative Scar Scale. Adverse events were also assessed.

Results: For the 45 participants who completed the studies, mean age was 22 years, 76 percent were female, and all Fitzpatrick skin types were represented. At Week 24, 67 percent of participants achieved treatment success (≥2-grade reduction in IGA score from baseline and clear/almost clear skin), with significant reductions in inflammatory and noninflammatory lesions (88% and 68%, respectively; p<0.001 vs. baseline, both). Decreases from baseline at Week 24 in PIH (71%), PIE (77%), and scarring severity (33%) were statistically significant (p<0.001, all). Mean scores for skin dryness remained low (<0.15), and most participants (>70%) reported no tolerability issues across all time points. A total of seven adverse events occurred; four were related to the study product, and three led to study discontinuation.

Conclusion: CAB gel was well tolerated and led to significant and continued improvements in acne lesions, scarring, and dyspigmentation over six months of once-daily use. No new safety or tolerability signals were observed. These results support the long-term use of CAB as a topical acne treatment.

Funding/financial disclosures: Ortho Dermatologics

Atopic Dermatitis

Anchored matching-adjusted indirect comparison of the long-term maintenance of efficacy of tralokinumab and lebrikizumab

Presenters: Matthias Augustin,¹ April Armstrong,² Naiem Issa,^3–5 Anne Sohrt Petersen,⁶ Rie von Eyben,⁶ Teodora Festini,⁶ Tiago Torres^7,8

Affiliations: ¹University Medical Center Hamburg-Eppendorf (UKE), DE; ²University of Southern California, US; ³Forefront Dermatology, US; ⁴George Washington University School of Medicine and Health Sciences, US; ⁵University of Miami Miller School of Medicine, US; ⁶LEO Pharma A/S, DK; ⁷University of Porto, PT; ⁸Centro Hospitalar Universitário do Porto, PT

Introduction: Tralokinumab and lebrikizumab are interleukin (IL)-13 inhibitors used to treat moderate-to-severe atopic dermatitis (AD). No head-to-head studies have compared their efficacy to date. We conducted a matching-adjusted indirect comparison (MAIC) of the efficacy of tralokinumab and lebrikizumab at Week 52 in Week 16 responders.

Methods: A MAIC was performed using individual patient data from the ECZTRA 1&2 tralokinumab trials and aggregate data from the ADvocate 1&2 lebrikizumab trials. Endpoints were compared at Week 52 in patients who responded at Week 16, defined as patients achieving a 75-percent reduction in the Eczema and Severity Index from baseline (EASI75) or Investigator’s Global Assessment 0/1, with two-point or greater improvement (IGA 0/1). In both ECZTRA 1&2 and ADvocate 1&2, 16-week responders were rerandomized to receive placebo or active treatment (either tralokinumab 300mg or lebrikizumab 250mg, respectively) every two weeks (Q2W), or every four weeks (Q4W), for the 36-week maintenance period. During the maintenance period, patients who received rescue medication, discontinued treatment, or transferred to the escape arm were imputed as nonresponse for binary endpoints and imputed as last observation carried forward for continuous endpoints.

Patients in the ECZTRA trials were weighted to match those of the ADvocate trials based on the following baseline characteristics: age, sex, ethnicity, body mass index, mean AD duration, proportion with IGA of 3, mean EASI, mean Dermatology Life Quality Index (DLQI), mean worst daily pruritus numeric rating scale (pruritus NRS); and Week 16 characteristics: mean EASI, proportion of IGA 0/1 response, and mean pruritus NRS. The efficacy of tralokinumab and lebrikizumab relative to placebo at Week 52 were compared for the Q2W arms and Q4W arms, respectively. The efficacy outcomes analyzed include IGA 0/1, EASI75, EASI90, pruritus NRS four-point improvement (pruritus 4pt), and EASI percentage change from baseline (CfB). A sensitivity analysis was made by comparing the analyses generated by using the two estimands reported in the ADvocate 1&2 trials.

Results: Tralokinumab had comparable efficacy to lebrikizumab across all endpoints. The results for the Q2W endpoints were numerically in favor of tralokinumab, though none of the results were statistically significant for both doses. Risk differences for the outcomes for the Q2W arms were IGA 0/1: 1.2 percent (p=0.94), EASI75: 19.8 percent (p=0.13), EASI90: 1.5 percent (p=0.91), pruritus 4pt: 17.6 percent (p=0.34), and EASI CfB: 3.3 percent (p=0.46). Risk differences for the outcomes for the Q4W arms were IGA 0/1: –20.5 percent (p=0.22), EASI75: 15.7 percent (p=0.23), EASI90: –8.5 percent (p=0.51), pruritus 4pt: –2.7 percent (p=0.88), and EASI CfB: –0.5 percent (p=0.91). Sensitivity analysis showed similar outcomes.

Conclusion: Within the limitations of MAIC, comparable maintenance of efficacy was observed between tralokinumab and lebrikizumab after 52 weeks of treatment in 16-week responders.

Acknowledgements and Funding Sources: This study and editorial support from Alphabet Health (New York, NY) by Gina Sanchez, PhD, was sponsored by LEO Pharma A/S (Ballerup, Denmark). This work was previously presented at Fall Clinical 2024.

Clinical trial exit interviews in patients with moderate-to-severe chronic hand eczema: evaluation of treatment experiences with delgocitinib cream 20mg/g in the Phase III DELTA 1 trial

Presenters: Padma Mohandas,¹ Eric Simpson,² Lakshi Aldredge,³ Eydna Apol,⁴ Douglas Maslin,⁴ Delphine Pertus,⁴ Robert Bissonnette⁵

Affiliations: ¹Whipps Cross Hospital, Barts Health NHS Trust, UK; ²Oregon Health & Science University, US; ³VA Portland Health Care System, US; ⁴LEO Pharma A/S, DK; ⁵Innovaderm Research, Canada

Introduction: Clinical trial exit interviews can provide valuable insight into patients’ experiences and highlight the treatment benefits that are most meaningful to them. In the Phase III DELTA 1 (NCT04871711) trial, significantly more patients with moderate-to-severe chronic hand eczema (CHE) treated with the topical pan-Janus kinase (JAK) inhibitor delgocitinib cream 20mg/g versus cream vehicle achieved the primary endpoint of Investigator’s Global Assessment for CHE treatment success (IGA-CHE TS, defined as IGA-CHE score of 0/1 [clear/almost clear] with a ≥2-step improvement from baseline) at Week 16. Here, we summarize patient-reported treatment experiences in DELTA 1 and how they compare to achievement of IGA-CHE TS.

Methods: In DELTA 1, adults with moderate-to-severe CHE received delgocitinib cream or cream vehicle twice daily for 16 weeks. In this post hoc analysis, patients who completed treatment with delgocitinib cream were invited for a one-hour telephone/video call. Participants who were fluent in English and provided written consent were asked to describe changes (improvement, worsening, or minimal change) in signs/symptoms of CHE and to discuss impact on health-related quality of life (HRQoL). Verbatim interview transcripts were analyzed using artificial intelligence (AI) software (ATLASti.com).

Results: The 23 participants (male, n=9; female, n=14) who completed exit interviews had baseline characteristics consistent with the total population of DELTA 1. The majority of interview participants who discussed each individual key skin-related sign/symptom of CHE at Week 16 reported improvements in cracked skin (n=14/19), pain (n=15/20), redness (n=12/13), dryness (n=10/13), itch (n=10/14), and flaking (n=11/12). The majority felt “satisfied” or “very satisfied” with these sign/symptom improvements (n=13/23) and reported a positive impact on their HRQoL across multiple domains, including activities of daily living (n=12/22), emotional wellbeing (n=15/21), physical functioning (n=10/15), and social functioning (n=9/15). Although only four of 23 interview participants achieved IGA-CHE TS, all the participants not meeting IGA-CHE TS still reported improvement in at least one sign/symptom (n=19/19) with the majority reporting a positive impact on at least one HRQoL domain (n=15/19). These results highlight that IGA-CHE TS is a high threshold for defining treatment success and might not identify all participants with positive response to delgocitinib cream. Notably, no participants who did achieve IGA-CHE TS reported worsening in any signs/symptoms or HRQoL domains.

Conclusion: This analysis of exit interviews shows that delgocitinib cream 20mg/g provides meaningful improvement in signs/symptoms and HRQoL in patients with moderate-to-severe CHE, including a majority of participants who did not meet IGA-CHE TS at Week 16 still reporting satisfaction and treatment benefits across all relevant symptoms and signs of CHE.

Acknowledgements and Funding Sources: This analysis was sponsored by LEO Pharma A/S. Medical writing and editorial support from Alphabet Health by Jenisha Ghimire, PhD, and Clair Geary, PhD, was funded by LEO Pharma. This work was previously presented at Winter Clinical Hawaii 2025.

Delgocitinib cream 20mg/g in chronic hand eczema patients with skin fissures: efficacy, safety, and pharmacokinetics

Presenters: Lawrence F. Eichenfield,¹ Christopher G. Bunick,² Benjamin Ehst,³ Sven R. Quist,⁴ Irina Turchin,^5,6 Keith Baranowski,⁷ Umut Erhan,⁷ Douglas Maslin,^7,8 Marie Louise Østerdal,⁷ Marie-Noelle Crépy^9,10

Affiliations: ¹University of California San Diego School of Medicine, La Jolla, US; ²Yale University School of Medicine, New Haven, US; ³Oregon Medical Research Center, Portland, US; ⁴Helix Medical Excellence Center Mainz, Mainz, Germany; ⁵Brunswick Dermatology Center, Fredericton, Canada; ⁶Probity Medical Research, Waterloo, Canada; ⁷LEO Pharma A/S, Ballerup, Denmark; ⁸Addenbrooke’s Hospital, Cambridge, UK; ⁹University Hospital of Centre of Paris, Cochin Hospital, AP-HP, Paris, France; ¹⁰University Hospital of Centre of Paris, Hotel-Dieu Hospital, AP-HP, Paris, France

Introduction: Patients with CHE often have skin fissures, which are typically painful and difficult to treat. When treating fissures with topical therapies, the systemic exposure and safety, alongside efficacy, are of high importance due in part to the damaged skin barrier. Here, we examined efficacy, safety, and pharmacokinetics (PK) of delgocitinib cream in patients with fissures from two Phase III trials.

Methods: Adults with moderate-to-severe CHE receiving twice-daily delgocitinib cream 20mg/g or cream vehicle for 16 weeks in DELTA-1 (NCT04871711) or DELTA-2 (NCT04872101) were analyzed. Efficacy was based on the Hand Eczema Severity Index (HECSI) fissure score, defined as sum of fissure severity scores across five hand regions (range: 0–15). Responder rates for HECSI fissure 0 or 0/1 (clear/mild in a single region) and adverse event (AE) rates were assessed. Plasma concentrations of delgocitinib (DELTA-2) were compared with PK data from a Phase I trial (NCT05050279) of healthy adults receiving oral delgocitinib 1.5mg and IC₅₀ values from in vitro spiking of whole blood from healthy adults.

Results: At baseline, patients in the delgocitinib cream group with fissures (HECSI fissure >0, n=586) had a mean fissure score of 4.9 (standard deviation: 2.7) and showed greater disease severity versus patients without fissures (HECSI fissure 0, n=52) (mean HECSI: 73.6 vs. 43.3). From Weeks 2 to 16, more patients receiving delgocitinib cream versus cream vehicle achieved HESCI fissure 0 (Week 16: 40.8% vs. 18.3%, p<0.001) or 0/1 (Week 16: 55.3% vs. 29.7%, p<0.001). Median percent improvement in HECSI fissure score was greater from Weeks 1 to 16 in patients receiving delgocitinib cream versus cream vehicle (Week 16: 72.7% vs. 33.3%, p<0.001). No meaningful differences in safety were observed between delgocitinib cream–treated patients with versus without fissures at baseline (overall AEs: 45.6% vs. 46.2%; severe AEs: 2.0% vs. 5.8%). Delgocitinib geometric mean plasma concentrations (ng/mL) among patients with fissures at baseline (n=284) were minimal and decreased from Week 1 (0.23) and Week 4 (0.21) to Week 16 (0.12). These plasma concentrations were substantially lower compared with oral delgocitinib 1.5mg (7.22ng/mL) and whole blood IC₅₀ (24ng/mL).

Conclusion: Delgocitinib cream demonstrated efficacy, leading to complete resolution of fissures in 40 percent of patients and a comparable safety profile in patients with/without fissures. Additionally, systemic exposure of delgocitinib cream was negligible in patients with fissures at baseline.

Acknowledgements and Funding Sources: This analysis was sponsored by LEO Pharma. Medical writing and editorial support from Alphabet Health by Matthew Hartmann, PhD, was funded by LEO Pharma. This work was previously presented at Winter Clinical Hawaii 2025.

Improvement in atopic dermatitis signs and symptoms with once-daily and proactive twice-weekly roflumilast cream 0.15% or 0.05%: results from the 52-week Phase III INTEGUMENT-OLE trial in patients aged ≥2 years

Presenters: H. Chih-ho Hong,¹ Eric Simpson,² Lawrence F. Eichenfield,³ Alexandra Golant,⁴ Adelaide A. Hebert,⁵ Amy Paller,⁶ April Armstrong,⁷ Linda Stein Gold,⁸ Jonathan I. Silverberg,⁹ David Krupa,¹⁰ Patrick Burnett,¹⁰ Diane Hanna,¹⁰ Melissa S. Seal,¹⁰ Brett Stephenson¹⁰

Affiliations: ¹Probity Medical Research and Department of Dermatology and Skin Science, University of British Columbia, Surrey, BC; ²Oregon Health & Science University, Portland, OR; ³Rady Children’s Hospital–San Diego, University of California San Diego, San Diego, CA; ⁴Icahn School of Medicine at Mount Sinai, New York, NY; ⁵UTHealth McGovern Medical School, Houston, TX; ⁶Northwestern University Feinberg School of Medicine, Chicago, IL; ⁷David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA; ⁸Henry Ford Health System, Detroit, MI; ⁹George Washington University School of Medicine and Health Sciences, Washington, DC; ¹⁰Arcutis Biotherapeutics, Inc., Westlake Village, CA

Introduction: Roflumilast cream 0.15% and 0.05% demonstrated efficacy and safety for mild-to-moderate atopic dermatitis (AD) in six-year-olds or older and 2-to-5-year-olds, respectively, in randomized, vehicle-controlled, four-week, Phase III trials (INTEGUMENT-1/2 and INTEGUMENT-PED). Patients who completed INTEGUMENT-1/2 or INTEGUMENT-PED could enroll in a Phase III, open-label extension trial (INTEGUMENT-OLE/NCT04804605).

Methods: Patients received roflumilast cream 0.15% (≥6 years) or 0.05% (2–5 years) once daily for up to 52 weeks. Patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) 0 (clear) at/after OLE Week 4 transitioned to twice-weekly (BIW) application, which was continued as long as “disease control” (vIGA-AD 0/1 [clear/almost clear] and adequate AD sign/symptom control) was maintained. Efficacy endpoints, assessed from parent-study baseline, included vIGA-AD 0/1, Worst Itch-Numeric Rating Scale (WI-NRS) 0/1 (no/minimal itch), and mean body surface area affected (BSA). Safety and application-site tolerability were assessed.

Results: INTEGUMENT-OLE included 658 patients from INTEGUMENT-1/2 and 562 from INTEGUMENT-PED. At OLE week 52, vIGA-AD 0/1 rates were 55.7 percent (117/210) and 63.1 percent (234/371) for INTEGUMENT-1/2 and INTEGUMENT-PED populations, respectively; WI-NRS 0/1 were 47.1 percent (49/104) and 40.7 percent (116/285); mean BSA decreased from baseline (14.8% to 3.7%; 22.3% to 4.9%). At/after OLE Week 4, 19.8 percent (130/658) of patients from INTEGUMENT1/2 and 30.2 percent (170/562) from INTEGUMENT-PED transitioned to BIW application and had median durations of  “disease control” of 281 and 238 days, respectively (Kaplan–Meier estimates). Treatment-related adverse event (AE) rates during the OLE were 4.7 percent (INTEGUMENT-1/2) and 2.5 percent (INTEGUMENT-PED). Application-site dermatitis and pain AEs were reported for 0.8 percent and 0.5 percent of patients, respectively, from INTEGUMENT-1/2, and (during any OLE visit) 0.4 to 2.1 percent of patients self-reported stinging and/or burning that caused definite discomfort. Application-site pain and pruritus AEs were reported for 0.7 percent and 0.5 percent of patients, respectively, from INTEGUMENT-PED, and 0.4 percent to 1.8 percent of caregivers reported a severe hot, tingling/stinging sensation that caused definite discomfort.

Conclusion: In patients aged two years or older, roflumilast cream decreased AD signs/symptoms, including BSA, and maintained improvements during long-term treatment. Proactive BIW application maintained “disease control” for over 200 days. Roflumilast cream was well tolerated and is an appropriate alternative to topical corticosteroids and calcineurin inhibitors for AD treatment.

Long-term safety and efficacy of tralokinumab in adults and adolescents with moderate-to-severe atopic dermatitis treated for up to 6 years

Presenters: Andrew Blauvelt,¹ Vivian Laquer,² Richard G. Langley,³ H. Chih-ho Hong,⁴ Christian Bjerregård Øland,⁵ Le Gjerum,⁵ Ann-Marie Tindberg,⁵ Kristian Reich⁶

Affiliations: ¹Blauvelt Consulting, LLC, Annapolis, MD, US; ²First OC Dermatology Research, Fountain Valley, CA, US; ³Dalhousie University, Halifax, NS, CA; ⁴Dr. Chih-ho Hong Medical Inc., Surrey, BC, CA; ⁵LEO Pharma A/S, Ballerup, DK; ⁶University Medical Center Hamburg-Eppendorf, Hamburg, DE

Introduction: Tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in patients 12 years of age or older. ECZTEND (NCT03587805) is an open-label extension study evaluating the long-term safety and efficacy of tralokinumab in patients with moderate-to-severe AD. Interim analyses previously demonstrated the benefit-risk profile of tralokinumab in patients followed up to 3.5 years in ECZTEND; here, we present the final study results.

Methods: Patients completing any of nine parent trials (ECZTRA 1–8 and the TraSki investigator-initiated study) were able to enter ECZTEND. Patients in ECZTEND received tralokinumab 300mg every other week, with topical corticosteroids and/or calcineurin inhibitors allowed. The primary objective of ECZTEND was to assess safety of tralokinumab treatment from baseline up to Week 268. Secondary objectives were to assess efficacy, including proportions of patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1; clear/almost clear skin) or 75-percent or greater improvement in Eczema Area and Severity Index (EASI75) from parent trial baseline, and quality of life (QoL) measures up to Week 248.

Results: In total, 1,672 patients were treated with tralokinumab for up to 5.1 years in ECZTEND. Median exposure was 2.6 years, with 4,466.2 total patient years of exposure. Maximum tralokinumab exposure, including the parent trial period, was 6.1 years. In ECZTEND, exposure-adjusted incidence rate (IR) of patients with one or more treatment-emergent adverse events (AEs) was 114.3, which was lower than the initial 16-week treatment period of the parent trials (IR=424.8 for tralokinumab; IR=475.3 for placebo). Over five years of ECZTEND, serious AEs were reported in 9.0 percent of patients (IR=3.54). AEs that led to permanent discontinuation of treatment occurred in 4.5 percent of patients (IR=1.71). The most frequently reported AEs (≥5% of patients) were nasopharyngitis (22.2%), dermatitis atopic (21.4%), coronavirus infection (17.9%), upper respiratory tract infection (8.8%), headache (6.8%), and conjunctivitis (6.2%). Predefined AEs of special interest (eye disorders, skin infections requiring systemic treatment, eczema herpeticum, malignancies) were observed at rates similar to, or lower than, the initial treatment period of the parent trials. At Week 248, response rates (95% confidence interval) for IGA 0/1 and EASI75 were 66.7 percent (56.1–75.8%) and 92.9 percent (85.3–96.7%), respectively. Additionally, itch, sleep, and QoL improvements were sustained at levels equivalent to no-to-mild disease throughout ECZTEND.

Conclusion: Long-term use of tralokinumab, up to one year in parent trials plus up to five years in ECZTEND was well tolerated with no new safety signals identified in patients aged 12 years and up with moderate-to-severe AD. Tralokinumab treatment demonstrated robust long-term efficacy with sustained improvements in AD signs, symptoms, and QoL.

Acknowledgements and Funding Sources: This analysis and medical writing support from Alphabet Health by Krista Mills, PhD, and Clair Geary, PhD, was funded by LEO Pharma A/S, Ballerup, Denmark. LEO Pharma and the authors thank all study investigators for their contributions and the patients who participated in this study. This work was previously presented at Fall Clinical 2024.

Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate-to-severe atopic hand eczema

Presenters: David Cohen,¹ Anthony Bewley,² Andreas Wollenberg,³ H. Chih-ho Hong,⁴ April Armstrong,⁵ Emilie Jonsen,⁶ Douglas Maslin,⁶ Henrik Thoning,⁶ Rie von Eyben,⁶ Raj Chovatiya⁷

Affiliations: ¹NYU Grossman School of Medicine, New York, NY, US; ²Barts Health NHS Trust & QMUL, London, UK; ³Ludwig-Maximilian University, Munich, Germany; ⁴University of British Columbia, Vancouver, BC, Canada; ⁵UCLA, Los Angeles, CA, UA; ⁶LEO Pharma A/S, Ballerup, Denmark; ⁷Rosalind Franklin University of Medicine and Science, Chicago, IL, US

Introduction: Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor that has demonstrated significant efficacy across chronic hand eczema (CHE) etiological subtypes, including atopic hand eczema (AHE), and is well tolerated. Dupilumab is an interleukin (IL)-4/IL-13 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). As no head-to-head studies have been conducted, an analysis was performed comparing the efficacy of delgocitinib and dupilumab in patients with AHE in a matching-adjusted indirect comparison (MAIC) based on the DELTA 1 and 2 and LIBERTY-AD-HAFT trials.

Methods: DELTA 1/2 (NCT04871711/NCT04872101) were identically designed Phase III trials in which adults with moderate-to-severe CHE were randomized 2:1 to double-blind treatment with delgocitinib cream 20mg/g or cream vehicle twice daily for 16 weeks. LIBERTY-ADHAFT (NCT04417894) was a Phase III trial in which adults and adolescents (≥12 years) with moderate-to-severe AD with hand and/or foot involvement were randomized to subcutaneous injection with dupilumab or placebo every two weeks for 16 weeks. An anchored MAIC was conducted using individual patient data (IPD) from DELTA 1/2 and aggregate published data from LIBERTY-AD-HAFT, with cream vehicle and placebo arms as the common anchor. IPD from patients with AHE as the primary subtype in DELTA 1/2 were weighted to match age, race, sex, and baseline Hand Eczema Severity Index (HECSI) score in LIBERTY-AD-HAFT. Endpoints compared were 75-percent or greater improvement in HECSI (HECSI75), HECSI90, and HECSI percent improvement from baseline at Week 16. Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE) response in the DELTA 1/2 trials and Hand and Foot Investigator’s Global Assessment (HF-IGA) response in the LIBERTY-AD-HAFT trial were also compared, although the two scales differed in how response was defined.

Results: LIBERTY-AD-HAFT included 133 patients (dupilumab, n=67; placebo, n=66) while DELTA 1/2 included 959 patients, 345 with AHE (delgocitinib, n=225; cream vehicle, n=120). The effective sample size after weighted matching was 201 (delgocitinib, n=128; cream vehicle, n=73). Anchor-adjusted odds ratios comparing delgocitinib versus dupilumab were 1.1 (95% confidence interval [CI]: 0.3, 3.4; p=0.890) for IGA-CHE/HF-IGA score 0/1, 1.2 (95% CI: 0.4, 3.2; p=0.773) for HECSI75, and 1.3 (95% CI: 0.4, 4.9; p=0.661) for HECSI90, while the anchor-adjusted response difference for HECSI percent improvement was 11.7 percent (95% CI: −9.2%, 32.7%); p=0.273). Treatment differences were not statistically significant; however, all point estimates were numerically in favor of delgocitinib.

Conclusion: The efficacy of topical delgocitinib and the biologic dupilumab in patients with AHE are comparable at 16 weeks, with all results being numerically in favor of delgocitinib, though not statistically significant.

Acknowledgements and Funding Sources: These analyses and editorial support from Alphabet Health by Gina Sanchez, PhD, was funded by LEO Pharma A/S (Ballerup, Denmark). This work was previously presented at EADV 2024.

Real-world effectiveness of tralokinumab in adults with atopic dermatitis: interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study

Presenters: April Armstrong,¹ Ahmed Ameen,² Jerry Bagel,³ Teodora Festini,⁴ Ulla Ivens,⁴ Ida Vittrup,⁴ Andrew E. Pink⁵

Affiliations: ¹University of California Los Angeles, US; ²NMC Specialty Hospital, UAE; ³Windsor Dermatology, US; ⁴LEO Pharma A/S, DK; ⁵St John’s Institute of Dermatology, Guy’s and St Thomas’ Hospitals, UK

Introduction: Atopic dermatitis (AD) is a chronic skin disease affecting multiple areas, including the head and neck (H&N) region, reported in 72 percent of patients with moderate-to-severe AD. H&N AD, in particular, is associated with social embarrassment, stigmatization, and negative impact on patients’ quality of life (QoL) and mental health. Tralokinumab, a monoclonal antibody specifically targeting interleukin-13, is indicated for treatment of moderate-to-severe AD. Here, we evaluated the effectiveness of tralokinumab in patients with H&N AD in an interim analysis (IA) of the noninterventional TRACE study.

Methods: TRACE is an international, prospective, single-cohort study of adult patients with AD (enrolled between November 2021 and July 2023) prescribed tralokinumab according to national approved labels. At IA data cut-off (October 15, 2023), not all patients had completed all visits. This analysis included patients with AD involvement on face, scalp, and neck at baseline. Outcomes collected included AD localization and overall AD measures, including Investigator’s Global Assessment (IGA), Dermatology Life Quality Index (DLQI), RECAP, Peak Pruritus Numeric Rating Scale (PP-NRS), and/or Sleep NRS per individual clinical practice. Data presented as-observed.

Results: In patients with H&N AD at baseline (79.5% of full analysis set), the percentages that still reported AD on the H&N area decreased to 67.2 percent (363/540) at three months (3M) and to 52.1 percent at 9M. Percentage with IGA 0/1 increased from 1.4 percent (9/650) at baseline to 33.6 percent (172/512) at 3M, 48.4 percent (121/250) at 6M, and 57.4 percent (58/101) at 9M of tralokinumab. The percentages of patients with IGA 4 decreased from 37.7% (245/650) at baseline to 4.7 percent (24/512) at 3M, 2.8 percent (7/250) at 6M, and 2.0 percent (2/101) at 9M. Among patients with baseline IGA of 2 or greater, the percentages achieving two-point or greater improvement in IGA increased from 46.4 percent (220/474) at 3M to 59.1 percent (140/237) at 6M, and 71.6 percent (68/95) at 9M. Among patients with baseline DLQI of 6 or greater, the majority achieved six-point or greater reduction in DLQI with tralokinumab: 57.9 percent (84/145) at 3M, 63.6 percent (49/77) at 6M, and 74.4 percent (32/43) at 9M. Mean PP-NRS improved from 6.4 (n=387) at baseline to 4.2 (n=213) at 3M, 3.5 (n=111) at 6M, and 3.3 (n=59) at 9M. Mean Sleep NRS improved from 5.2 (n=305) at baseline to 2.8 (n=170) at 3M, and 2.3 at 6M and 9M (n=84 and n=53, respectively) of tralokinumab. Similar improvements were observed across endpoints in both dupilumab-naïve (n=154) and dupilumab-experienced (n=501) patients, despite higher baseline disease severity in dupilumab-naïve patients.

Conclusion: Up to 9M months of tralokinumab treatment in a real-world setting reduced H&N involvement and improved disease severity and QoL in patients with AD in the difficult to treat H&N area; all improvements were similar regardless of prior dupilumab use.

Acknowledgements and Funding Sources: This analysis was sponsored by LEO Pharma A/S. Medical writing and editorial support from Alphabet Health by Jenisha Ghimire, PhD, was funded by LEO Pharma A/S, Ballerup, Denmark. This work was previously presented at EADV 2024.

“Super-response” following treatment with delgocitinib cream 20mg/g in a subgroup of patients with moderate-to-severe chronic hand eczema

Presenters: April W. Armstrong,¹ Claire Bernier,² Robert Bissonnette,³ Raj Chovatiya,^4,5 Nina Magnolo,⁶ Darryl P. Toth,^7,8 Keith Baranowski,⁹ Douglas Maslin,^9,10 Shannon K.R. Schneider,¹¹ Henrik Thoning,⁹ Jonathan I. Silverberg¹²

Affiliations: ¹Division of Dermatology, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, CA; ²Department of Dermatology, University Hospital Nantes, Nantes, France; ³Innovaderm Research, Montreal, Québec City, Canada; ⁴Rosalind Franklin University of Medicine and Science Chicago Medical School, North Chicago, IL, US; ⁵Center for Medical Dermatology + Immunology Research, Chicago, IL, US; ⁶Department of Dermatology and Venereology, University Hospital Münster, Münster, Germany; ⁷XLR8 Medical Research, Windsor, Ontario, Canada; ⁸Probity Medical Research, Windsor, Ontario, Canada; ⁹LEO Pharma A/S, Ballerup, Denmark; ¹⁰Department of Dermatology, Addenbrooke’s Hospital, Cambridge, UK; ¹¹LEO Pharma Inc., Madison, NJ, US; ¹²Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, US

Introduction: In the DELTA-1 (NCT04871711) and DELTA-2 (NCT04872101) Phase III trials, delgocitinib cream 20mg/g demonstrated significant improvement in all efficacy endpoints in adults with moderate-to-severe chronic hand eczema (CHE). Here we investigated the depth and consistency of treatment response in patients with moderate-to-severe CHE treated with delgocitinib cream 20mg/g for 16 weeks in DELTA-1 and DELTA-2 Phase III trials as well as the maintenance of treatment response after up to 36 weeks off delgocitinib cream 20mg/g treatment in the DELTA3 extension trial.

Methods: In the DELTA-1 and DELTA-2 Phase III trials, adults with moderate-to-severe CHE received twice daily delgocitinib cream (n=636) or cream vehicle (n=319) for 16 weeks optionally followed by a 36-week extension trial (NCT04949841). Outcomes assessed included Hand Eczema Symptom Diary (HESD) itch or pain scores, Dermatology Life Quality Index (DLQI), Hand Eczema Severity Index (HECSI), and Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE).

Results: At Week 16, more patients receiving delgocitinib cream versus cream vehicle achieved HESD itch 0/1 (30.0% vs. 9.4%), HESD pain 0/1 (35.2% vs. 16.0%), or DLQI 0/1 (33.3% vs. 13.9%). In delgocitinib cream–treated patients, 48.0 percent achieved at least 1 “0/1” outcome (vs. 23.8% with cream vehicle) and 19.2% achieved all three outcomes (vs. 5.4% with cream vehicle). Greater percentages of patients receiving delgocitinib cream versus cream vehicle consistently (at Weeks 4, 8, 12, and 16) achieved four-point or greater reduction from baseline in HESD itch (24.1% vs. 6.6%) or pain (25.0% vs. 9.0%) or 75-percent or greater improvement in HECSI (27.3% vs. 8.1%). Among patients receiving delgocitinib cream who achieved IGA-CHE 0 at Week 16, 32.9 percent and 15.7 percent maintained IGA-CHE 0 after eight and 16 weeks off treatment, respectively.

Conclusion: Delgocitinib cream 20mg/g provided a “super-response” in a subgroup of patients exhibiting deep and consistent treatment responses, equivalent to little-to-no itch, pain, or negative impact on quality of life and/or consistent improvement in disease extent/severity. One-third of IGA-CHE 0 responders exhibited prolonged treatment response after eight weeks off treatment.

Acknowledgements and Funding Sources: This analysis was sponsored by LEO Pharma. Medical writing and editorial support from Alphabet Health by Matthew Hartmann, PhD, was funded by LEO Pharma. This work was previously presented at AAD 2025.

 

Treatment-free disease control after tralokinumab in patients with moderate-to-severe atopic dermatitis

Presenters: Andrew Blauvelt,¹ Tina Bhutani,² Ben Ehst,³ Naiem Issa,^4–6 Matthew Zirwas,^7–9 Ulla Ivens,¹⁰ Hannah Lo,¹¹ Shannon Schneider,¹¹ Raj Chovatiya^12,13

Affiliations: ¹Blauvelt Consulting, LLC, Annapolis, MD, US; ²University of California San Francisco, San Francisco, CA, US; ³Oregon Medical Research Center, Portland, OR, US; ⁴Forefront Dermatology, Vienna, VA, US; ⁵University of Miami Miller School of Medicine, Miami, FL, US; ⁶George Washington University School of Medicine and Health Sciences, Washington, DC, US; ⁷Ohio University, Athens, OH, US; ⁸DOCS Dermatology, Bexley, OH, US; ⁹Probity Medical Research, Bexley, OH, US; ¹⁰LEO Pharma A/S, Ballerup, DK; ¹¹LEO Pharma Inc., Madison, NJ, US; ¹²Rosalind Franklin University of Medicine and Science, North Chicago, IL, US; ¹³Center for Medical Dermatology + Immunology Research, Chicago, IL, US

Introduction: Tralokinumab, a monoclonal antibody targeting interleukin (IL)-13, is approved for treatment of moderate-to-severe atopic dermatitis (AD) in individuals 12 years of age or older.

Methods: Enduring treatment-free disease control was assessed post hoc using pooled data from Phase III ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885) patients rerandomized to placebo after achieving primary endpoints (Investigator’s Global Assessment [IGA] 0/1 and/or ≥75% improvement in Eczema Area and Severity Index [EASI75]) at Week 16 with tralokinumab once every two weeks (Q2W; n=73). Treatment-free disease control was defined as no use of rescue therapy (ie, topical corticosteroid [TCS]), no transfer to open-label arm (tralokinumab Q2W + optional TCS), and no permanent trial discontinuation due to lack of efficacy.

Results: Patients maintained treatment-free disease control for a median of 22.3 weeks. At 26 weeks off treatment, 38.4 percent (28/73) of patients maintained treatment-free disease control, with 32.1 percent (9/28) and 17.9 percent (5/28) of those patients meeting IGA 0 and Itch Numeric Rating Score (NRS) 0/1, respectively. Patients who maintained treatment-free disease control had lower baseline mean body surface area (BSA; 33.6% vs. 52.6%) and EASI (25.3 vs. 31.4) and more robust Week 16 response (eg, IGA 0: 25% [7/28] vs. 0% [0/45]) than those who did not. Of patients who transferred to open-label tralokinumab after experiencing a predetermined decline from their Week 16 response (n=31), 69 percent regained IGA 0/1 or EASI75 by 24 weeks of open-label treatment, with a median recapture time of 12.1 weeks.

Conclusion: Approximately 40 percent of Week 16 responders maintained treatment-free disease control for six months with no rescue therapy, indicating that some patients might experience a remittive effect following specific neutralization of IL-13 with tralokinumab.

Acknowledgments and Funding Sources: The analyses and medical writing support were funded by LEO Pharma Inc., Madison, NJ, US. The authors would like to thank Oluf Hansen for assisting with the statistical analyses. Medical writing support was provided by Alphabet Health from Venecia Valdez, PhD, and Clair Geary, PhD. This work was previously presented at the 82nd Annual Meeting of the Society for Investigative Dermatology (SID), May 7–10, 2025.

Miscellaneous

Efficacy and safety of efinaconazole 10% topical solution for treatment of mild-to-moderate onychomycosis: pooled analysis of two Phase III trials by race

Presenters: Shari R. Lipner, MD, PhD;¹ Aditya K. Gupta, MD, PhD;^2,3 Tracey C. Vlahovic, DPM, FFPM, RCPS;⁴ Ted Rosen, MD, FAAD;⁵ Boni Elewski, MD;⁶ Su Yong Choi, PharmD;⁷ Eric Guenin, PharmD, PhD, MPH;⁷ Linda Stein Gold, MD⁸

Affiliations: ¹Weill Cornell Medicine, New York, NY, US; ²Mediprobe Research Inc., London, ON, Canada; ³Division of Dermatology, Department of Medicine, Temerty Faculty of Medicine, University of Toronto, ON, Canada; ⁴Samuel Merritt University College of Podiatric Medicine, Oakland, CA, US; ⁵Baylor College of Medicine, Houston, TX, US; ⁶University of Alabama at Birmingham School of Medicine, Birmingham, AL, US; ⁷Ortho Dermatologics,* Bridgewater, NJ, US; ⁸Henry Ford Hospital, Detroit, MI, USA

*Ortho Dermatologics is a division of Bausch Health US, LLC

Introduction: Clinical efficacy/safety data for toenail onychomycosis treatments in patients with skin of color are limited. This post hoc analysis of two Phase III trials of topical efinaconazole 10% solution was conducted to evaluate its efficacy/safety in participants with onychomycosis categorized by race.

Methods: Data were pooled from two multicenter, double-blind, Phase III trials (NCT01007708, NCT01008033). Participants aged 18 to 70 years with mild-to-moderate distal lateral subungual onychomycosis in one or more great toenails (n=1,655) were randomized (3:1) to once-daily efinaconazole 10% or vehicle for 48 weeks. Efficacy endpoints at Week 52 included rates of mycologic cure (negative potassium hydroxide [KOH] examination + negative fungal culture), complete cure (0% clinical involvement + mycologic cure), complete/almost complete cure (≤5% clinical involvement + mycologic cure), and clinical efficacy (<10% clinical involvement only). Adverse events (AEs) were assessed. Participants were categorized by self-reported race: White (n=1,251), Asian (n=269), or Black/African American (n=98).

Results: At Week 52, more participants treated with efinaconazole versus vehicle achieved complete cure (White, 14.7% vs. 2.0%; Asian, 27.5% vs. 13.0%; Black, 12.9% vs. 7.1%), complete/almost complete cure (22.8% vs. 4.6%; 35.5% vs. 18.8%; 25.7% vs. 7.1%, respectively), and clinical efficacy (31.2% vs. 8.6%; 46.0% vs. 23.2%; 31.4% vs. 21.4%, respectively). Over half of White (53.4%), Asian (56.5%), and Black (61.4%) efinaconazole-treated participants achieved mycologic cure versus only 10.7 to 30.4 percent with vehicle. Most treatment-emergent AEs with efinaconazole were mild-to-moderate, with low discontinuation rates due to AEs in all subgroups (<6%).

Conclusion: Topical efinaconazole 10% showed good efficacy/safety in White, Asian, and Black participants with mild-to-moderate onychomycosis, although generalizability of the smaller Black population results might be limited. These results were generally consistent with the overall Phase III populations and demonstrated that efinaconazole is an efficacious treatment for patients with skin of color.

Funding/financial disclosures: Ortho Dermatologics

 

Psoriasis

Efficacy and safety of once-daily roflumilast foam 0.3% for psoriasis of the scalp and body involving knees/elbows: subgroup results from the Phase III ARRECTOR trial

Presenters: Melinda J. Gooderham,¹ Tina Bhutani,² Melodie Young,³ April Armstrong,⁴ Mark Lebwohl,⁵ Michael Bukhalo,⁶ Laura K. Ferris,⁷ Jennifer C. Jaworski,⁸ Saori Kato,⁸ David Krupa,⁸ Melissa S. Seal,⁸ Diane Hanna⁸

Affiliations: ¹SKiN Centre for Dermatology, Probity Medical Research, Queen’s University, Kingston, ON; ²Synergy Dermatology, San Francisco, CA; ³Mindful Dermatology, Modern Research Associates, Dallas, TX; ⁴University of California Los Angeles, Los Angeles, CA; ⁵Icahn School of Medicine at Mount Sinai, New York, NY; ⁶Rosalind Franklin University of Medicine and Science Chicago Medical School, Arlington Dermatology, Rolling Meadows, IL; ⁷University of North Carolina, Chapel Hill, NC; ⁸Arcutis Biotherapeutics, Inc., Westlake Village, CA

Introduction: Poor absorption in areas with thick stratum corneum (eg, knees/elbows) can complicate topical psoriasis treatment. Roflumilast foam 0.3% is approved for the treatment of seborrheic dermatitis in patients aged nine years or older and plaque psoriasis of the scalp and body in patients aged 12 years or older. Outcomes in patients with psoriasis and baseline knee/elbow involvement were assessed.

Methods: In the Phase III ARRECTOR/NCT05028582 trial, patients aged 12 years or older with psoriasis of the scalp and body (maximum body surface area ≤25%, at least moderate Scalp-Investigator’s Global Assessment [IGA], and at least mild Body-IGA [B-IGA]) were randomized to apply roflumilast foam 0.3% or vehicle foam once daily for eight weeks. Endpoints included B-IGA success (clear/almost clear plus ≥2-grade improvement), 75-percent or greater improvement in Psoriasis Area and Severity Index (PASI75), and safety; all p-values are nominal.

Results: At baseline, 71 percent (199/281) of the roflumilast group and 72 percent (109/151) of the vehicle group had knee/elbow involvement. After eight weeks, B-IGA success was significantly higher with roflumilast versus vehicle (43% vs. 18%; p<0.001). Significantly higher proportions (each p<0.001) of those with knee involvement achieved regional lower-limb PASI75/100 with roflumilast (39%/31%) versus vehicle (10%/8%); for elbow involvement, significantly higher proportions achieved upper-limb PASI75/100 (42%/30% vs. 19%/13%). Improvements with roflumilast versus vehicle were also observed for individual PASI components. Safety in patients with knee/elbow involvement was consistent with the overall population.

Conclusion: Once-daily application of roflumilast foam 0.3% provided significant improvement across multiple efficacy measures in patients with psoriasis of the scalp and body involving knees/elbows.

 

Roflumilast foam 0.3% in patients with psoriasis of the scalp and body: improvements in patient-reported outcomes in the ARRECTOR trial

Presenters: Melinda J. Gooderham,¹ Javier Alonso-Llamazares,² Neal Bhatia,³ Laura K. Ferris,⁴ Leon Kircik,^5–7 Wei Jing Loo,⁸ Kim A. Papp,⁹ David Krupa,¹⁰ Melissa S. Seal,¹⁰ Diane Hanna,¹⁰ David R. Berk,¹⁰ Patrick Burnett¹⁰

Affiliations: ¹SKiN Centre for Dermatology, Probity Medical Research, and Queen’s University, Peterborough, ON; ²Driven Research LLC, Coral Gables, FL; ³Therapeutics Clinical Research, San Diego, CA; ⁴University of North Carolina, Department of Dermatology, Chapel Hill, NC; ⁵Icahn School of Medicine at Mount Sinai, New York, NY; ⁶Indiana University School of Medicine, Indianapolis, IN; ⁷Physicians Skin Care, PLLC and Skin Sciences, PLLC, Louisville, KY; ⁸DermEffects, Probity Medical Research, and Western University, London, ON; ⁹Probity Medical Research and Alliance Clinical Trials, Waterloo, ON, and Temerty School of Medicine, University of Toronto, Toronto, ON; ¹⁰Arcutis Biotherapeutics, Inc., Westlake Village, CA

Introduction: Psoriasis of the scalp or body negatively affects quality of life, with patients considering pruritus the most burdensome symptom. Once-daily roflumilast foam 0.3% is a potent phosphodiesterase 4 inhibitor approved for treatment of psoriasis of the scalp and body.

Methods: The Phase III ARRECTOR trial (NCT05028582) was conducted in patients aged 12 years or older with psoriasis of the scalp and body of at least moderate (≥3) Scalp-Investigator’s Global Assessment (S-IGA) and mild (≥2) Body-IGA (B-IGA), and affecting 25 percent or less of body surface area overall. Patients were randomized 2:1 to apply roflumilast foam 0.3% or vehicle foam once daily for eight weeks. Patient-reported outcomes included Scalp Itch-Numeric Rating Scale (SI-NRS), Worst Itch-NRS (WI-NRS), Psoriasis Symptom Diary (PSD; ≥18 years only), and Scalpdex. All p-values are nominal.

Results: There were 281 and 151 patients enrolled into the roflumilast foam 0.3% and vehicle foam groups, respectively. In patients with SI-NRS and/or WI-NRS 2 or greater at baseline, greater proportions of the roflumilast group than the vehicle group achieved no/minimal itch (0/1) at Week 8 (SI-NRS 0/1: 52.3% vs. 24.1%; p<0.0001; WI-NRS 0/1: 55.4% vs. 19.8%; p<0.0001). Consistent improvement was observed across PSD domains of patient-reported signs and symptoms of psoriasis (severity and bothersomeness), as well as improvement in emotional domains (embarrassment). Significantly greater reductions were observed for roflumilast versus vehicle at Week 8 in Scalpdex total score (–23.4 vs. –12.8; p<0.0001), and Scalpdex domain scores (emotions: –23.1 vs. –12.4; symptoms: –29.0 vs. –15.0; function: –20.7 vs. 11.7; all p<0.0001).

Conclusion: Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with psoriasis of the scalp and body.