Efficacy and Safety of Fixed-dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants with Moderate to Severe Acne

J Clin Aesthet Dermatol. 2025;18(4):10–16.

by Valerie D. Callender, MD; Andrew F. Alexis, MD, MPH; Neal Bhatia, MD; Julie C. Harper, MD; Hilary Baldwin, MD; Eric Guenin, PharmD, PhD, MPH; and Leon H. Kircik, MD

Dr. Callender is with Callender Dermatology and Cosmetic Center in Glenn Dale, Maryland, and the Howard University College of Medicine in Washington, District of Columbia. Dr. Alexis is with Weill Cornell Medicine in New York, New York. Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. Dr. Harper is with the Dermatology & Skin Care Center of Birmingham in Birmingham, Alabama. Dr. Baldwin is with The Acne Treatment and Research Center in Brooklyn, New York, and Robert Wood Johnson University Hospital in New Brunswick, New Jersey. Dr. Guenin is with Ortho Dermatologics, a division of Bausch Health US, LLC, in Bridgewater, New Jersey. Dr. Kircik is with the Icahn School of Medicine at Mount Sinai in New York, New York; Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC in Louisville, Kentucky.

FUNDING: This study was funded by Ortho Dermatologics.

DISCLOSURES: Dr. Callender has served as an investigator, consultant, or speaker for Acne Store, Almirall, Aerolase, AbbVie, Allergan Aesthetics, Avava, Avita Medical, Beiersdorf, Cutera, Dermavant, Eirion Therapeutics, Eli Lilly, Galderma, Janssen, Jeune Aesthetics, L’Oréal, Ortho Dermatologics, Pfizer, Prollineum, Regeneron, Scientis, Sente, SkinBetter Science, SkinCeuticals, Symatese, Teoxane, and UpToDate. Dr. Alexis has received grants (funds to institution) from LEO Pharma, Amgen, Galderma, Arcutis, Dermavant, AbbVie, Castle, and Incyte; advisory board/consulting fees from LEO Pharma, Galderma, Pfizer, Sanofi-Regeneron, Genzyme, Dermavant, Beiersdorf, Ortho Dermatologics, L’Oreal, BMS, Bausch Health, UCB, Arcutis, Janssen, Allergan, Almirall, AbbVie, Amgen, VisualDx, Eli Lilly, Swiss American, Cutera, Cara, EPI, Incyte, Castle, Apogee, Canfield, Alphyn, Avita Medical, Genentech, and Boehringer Ingelheim; speaker fees from Regeneron, Sanofi-Genzyme, BMS, L’Oreal, Janssen, J&J, and Aerolase; equipment (loan to institution) from Aerolase; and royalties from Springer, Wiley-Blackwell, Wolters Kluwer Health, and Elsevier. Dr. Bhatia has served as advisor, consultant, and investigator for AbbVie, Almirall, Biofrontera, BI, Brickell, BMS, EPI Health, Ferndale, Galderma, Incyte, ISDIN, J&J, LaRoche-Posay, LEO Pharma, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, Verrica, and Vyne. Dr. Harper has received honoraria from Almirall, Cutera, Galderma, LaRoche-Posay, Ortho Dermatologics, and Sun Pharma. Dr. Baldwin has served as advisor, investigator, and on the speakers’ bureaus for Almirall, Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and Sun Pharma. Dr. Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company. Dr. Kircik has served as either a consultant, speaker, advisor or an investigator for Allergan, Almirall, EPI Health, Galderma, Novartis, Ortho Dermatologics, and Sun Pharma.

ABSTRACT: Objective: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved fixed-dose, triple-combination acne treatment—demonstrated superior efficacy to vehicle and component dyads, with favorable safety/tolerability in Phase 2 and Phase 3 studies. In order to examine efficacy and safety of CAB in patients with darker skin phototypes, a post hoc analysis of clinical trial data of participants who self-identified as “Black or African American” was conducted. Methods: Data were pooled from two Phase 2 and two Phase 3, double-blind, 12-week studies (NCT03170388, NCT04892706, NCT04214639, NCT04214652). Eligible participants aged ≥9 years (≥12 years in NCT04892706) were randomized to once-daily CAB or vehicle. Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. Results: Of 1,115 participants randomized to CAB or vehicle, 156 (14%) were Black. At Week 12, 32.0 percent of CAB-treated participants achieved treatment success versus 18.3 percent with vehicle (P=0.07). Inflammatory and noninflammatory lesion reductions were significantly greater with CAB versus vehicle (68.8% vs. 51.4% and 57.8% vs. 45.5%, respectively; P<0.05, both). TEAE severity was mild to moderate, and hyperpigmentation mean scores remained at/below baseline value (0.7; 1=mild). Limitations: Studies were not powered to detect significant differences between CAB and vehicle for Black participants; therefore, P values are for informative purposes only. Conclusion: CAB gel was efficacious and well tolerated in Black participants with acne.

Keywords: Antibiotic, antimicrobial, clinical trial, combination treatment, retinoid, skin of color, topical

Trial registration: ClinicalTrials.gov identifiers: NCT03170388, NCT04892706, NCT04214639, NCT04214652

Introduction

Acne vulgaris is one of the most common skin disorders impacting individuals of all skin types, with an estimated global prevalence of over nine percent.¹ In general, acne pathogenesis involves abnormal keratinization, increased sebum production and inflammation, and follicular proliferation of Cutibacterium acnes.^2,3 Although etiology may be similar across skin types,^4,5 acne treatment in patients with darker skin phototypes involves unique considerations and is complicated by differences in acne presentation between patients with and without skin of color.⁶ For instance, more highly pigmented skin can be at a greater risk of acne and inflammation-related sequelae, including dyspigmentation and scarring, which may be more distressing than the acne itself.^7–9 As such, acne treatment guidelines for some melanin-rich populations (eg, India and other Asian countries, Ibero-Latin America) emphasize prevention or management of hyperpigmentation as an important objective for patients.^10–12 Early and aggressive acne treatment while minimizing irritation is important for the management and prevention of hyperpigmentation in patients with skin of color.¹³ Therefore, strategies to improve outcomes in these patients include consideration of drug tolerability and the use of treatments that address multiple pathogenic factors of acne.⁸

Current guidelines for acne management from the American Academy of Dermatology recommend topical treatments that target multiple processes of acne pathogenesis, with strong recommendations for the antimicrobial benzoyl peroxide (BPO), retinoids, and/or antibiotics.¹⁴ Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% polymeric mesh gel (CAB; Cabtreo®; Ortho Dermatologics) is the only fixed-dose, triple-combination topical product approved by the United States Food and Drug Administration for the treatment of acne.^15–17 Active ingredients in CAB gel target three of the four acne pathophysiologic mechanisms: clindamycin is an antibiotic; adapalene modulates cellular keratinization, differentiation, and proliferation; and BPO has antimicrobial, mild comedolytic, and keratolytic activity.^14,15,18 Additionally, all three active ingredients have anti-inflammatory properties^2,19,20 and are delivered in a single, pH-balanced gel.¹⁷ The anti-inflammatory properties of CAB gel may be key to acne treatment in patients with skin of color, for whom early and aggressive control of acne-associated inflammation is imperative.²¹

In a 12-week, randomized, double-blind Phase 2 trial of participants with moderate to severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with a favorable safety/tolerability profile.¹⁷ Furthermore, two similarly designed Phase 3 studies found CAB gel was well tolerated and associated with significantly greater treatment success and acne lesion reductions compared to vehicle.^22,23 To better understand the efficacy and safety of CAB gel in patients with darker skin phototypes, this post hoc analysis included participants pooled from two Phase 2 and two Phase 3 clinical studies who self-identified as “Black or African American” (hereafter referred to as Black).

Methods

Study design and participants. These analyses included data from two Phase 2 (NCT03170388; NCT04892706) and two Phase 3 (NCT04214639; NCT04214652), double-blind, 12-week studies. Eligible participants were aged ≥9 years (≥12 years in NCT04892706) with moderate to severe acne (a score of 3 or 4 on the Evaluator’s Global Severity Score [EGSS]). Eligible participants also needed to have the following facial lesions: ≥30 to ≤100 inflammatory (pustules, papules, and nodules), ≥35 to ≤150 noninflammatory (closed and open comedones), and two or fewer nodules. Participants were randomized either 1:1 (Phase 2 study NCT03170388) or 2:1 (Phase 2 study NCT04892706 and the Phase 3 studies) to receive once-daily clindamycin phosphate 1.2%/adapalene 0.15% gel/BPO 3.1% (CAB) or vehicle gel. One Phase 2 study included three additional dyad gel randomization arms: BPO 3.1%/adapalene 0.15%; clindamycin phosphate 1.2% /BPO 3.1%; and clindamycin phosphate 1.2%/adapalene 0.15%. The other Phase 2 study was a head-to-head comparison of CAB and branded adapalene 0.3%/BPO 2.5% gel (Epiduo® Forte, Galderma). Post hoc analyses were conducted in Black participants treated with CAB or vehicle gel; results from the dyad arms and the branded adapalene 0.3%/BPO 2.5% gel arms in the Phase 2 studies were not included, owing to the low number of Black participants. For optimal moisturization, cleaning, and protection of the skin, CeraVe® hydrating cleanser, CeraVe® moisturizing lotion (L’Oreal, New York, NY), and sunscreen were provided as needed.

Studies were carried out in accordance with principles of Good Clinical Practice and the Declaration of Helsinki. At all investigational sites, the study protocol was approved by the relevant independent ethics committees or institutional review boards. All participants or their legal guardians provided written informed consent.

Efficacy and safety assessments.Efficacy evaluations included inflammatory and noninflammatory lesion counts and treatment success, defined as the percentage of participants achieving ≥2-grade reduction from baseline in EGSS and a score of 0 (clear) or 1 (almost clear). Assessments were performed at baseline and at Weeks 2, 4, 8, and 12. At baseline and Week 12, participants completed the Acne-Specific Quality of Life (Acne-QoL) questionnaire, which covers four domains: self-perception, role-emotional, role-social, and acne symptoms.²⁴ Questions within each domain were scored from 0 (extremely) to 6 (not at all); increases from baseline in domain scores indicated improved quality of life. Investigator assessments of cutaneous safety (scaling, erythema, hypopigmentation, hyperpigmentation) and participant assessment of tolerability (itching, burning, stinging) were scored using a four-point scale (0=none, 1=mild, 2=moderate, 3=severe). Treatment compliance (assessed via product weight measurements and participant responses/diaries) was defined as participants missing less than five consecutive days of dosing and applying 80 to 120 percent of expected applications. Adverse events (AEs) were monitored throughout the study.

Statistical analysis. For these pooled post hoc analyses, only participants who self-reported their race as “Black/African American” were included. The intent-to-treat (ITT) population included all randomized participants who were provided study drug, and the safety population included all randomized participants who used study drug at least once.

Percent change in inflammatory and noninflammatory lesions at weeks without significant skewness were based on non-rank-transformed data; when significant skewness was observed, a nonparametric method was used to rank transform data prior to the analysis of covariance (ANCOVA), with a factor of treatment group and the respective baseline lesion count as a covariate. Treatment success was analyzed using a logistic regression test (using Firth’s Penalized Likelihood) with factor of treatment group. For Acne-QoL questionnaire responses, domain scores were transformed from 0 to 6 to 1 to 7 prior to ANCOVA with factor of treatment group and covariate of baseline domain score. For all efficacy assessments except Acne-QoL, multiple imputation was used to impute missing values using the Markov Chain Monte Carlo method. All statistical analyses were performed using SAS® version 9.4 or later. Statistical significance was based on two-tailed tests of the null hypothesis resulting in P≤0.05.

Treatment compliance and cutaneous safety/tolerability assessments were summarized using descriptive statistics. AEs were recorded and classified using Medical Dictionary for Regulatory Activities terminology. Imputations were not made for missing safety data.

Results

Participant demographics and baseline characteristics. Of 1,115 participants randomized to CAB or vehicle gel in the two Phase 2 and two Phase 3 studies, 156 (14%) self-identified as Black (n=88 CAB, n=68 vehicle) and were included in the ITT and safety populations. Baseline participant characteristics and demographics are presented in Table 1.

Nearly three-quarters of participants were female, and most participants (>90%) were not Hispanic/Latino. Although most participants had moderate acne at baseline, a slightly higher percentage of participants in the CAB group had severe acne compared to in the vehicle group (12.5% vs. 7.4%). Treatment compliance was high (>91%) across both CAB and vehicle treatment groups.

Efficacy. At Week 12, rates of treatment success were numerically greater in Black participants treated with CAB gel compared to vehicle (32.0% vs 18.3%; P=0.07). Images showing acne improvement in CAB-treated participants are shown in Figure 1.

Inflammatory and noninflammatory lesions reduced over time in CAB-treated participants, with significant improvement versus vehicle starting at Week 4 (P<0.05; Figure 2). At Week 12, least squares mean percent change from baseline in both inflammatory and noninflammatory lesions was significantly greater with CAB than with vehicle (inflammatory: -68.8% vs. -51.4%, noninflammatory: -57.8% vs. -45.5%; P<0.05, both).

Quality of life. Improvements in quality of life from baseline to Week 12 were greater with CAB versus vehicle across all four domains. Least squares mean increases from baseline in Acne-QoL scores were significantly greater with CAB versus vehicle in 3 of 4 domains (range: CAB, 6.0−9.1; vehicle, 4.0−6.8; P<0.05, all; Figure 3).

Safety and tolerability. The proportion of participants who reported any treatment-emergent adverse events (TEAEs) was higher in the CAB-treated group compared to vehicle (Table 2). Most TEAEs were of mild or moderate severity for both treatment groups and the only serious AE reported was not considered related to treatment. No participants discontinued the study owing to TEAEs. The most common treatment-related TEAEs were application site pain, exfoliation, and pruritus.

The mean scores for all cutaneous safety and tolerability assessments following CAB treatment were ≤0.7 (1=mild) at all study visits. As expected, transient increases in erythema, itching, burning, and stinging between Weeks 2 and 8 occurred with CAB treatment but returned close to baseline values by Week 12 (Figure 4). At baseline, just under half of all participants in the CAB group presented with hyperpigmentation (48.8%). Of note, hyperpigmentation mean scores in the CAB-treated participants remained at or below the baseline value (0.7) for all post-baseline visits. Further, the mean value of the worst (highest) cutaneous safety/tolerability score at any time post-baseline in the CAB treatment group was ≤0.8 (Table 3).

Discussion

In this pooled, post hoc analysis of two Phase 2 and two Phase 3 trials, the fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate to severe acne who self-identified as Black. Once-daily treatment with CAB gel was associated with significant reductions in both inflammatory and noninflammatory lesions compared to vehicle treatment at Week 12. Nearly one-third of patients treated with CAB achieved treatment success at Week 12 versus less than one-fifth with vehicle gel. Most TEAEs associated with CAB treatment were of mild to moderate severity and none led to discontinuations.

At Week 12, acne lesion reductions in CAB-treated Black participants were slightly lower than those observed in the overall study populations (inflammatory, 68.8% vs. 75.7%–80.1%; noninflammatory, 57.8% vs. 71.0%–73.3%). The slightly lower lesion reductions in Black participants may be partially explained by the low number of Black participants in the pooled population.^17,22 However, despite the relatively low number of participants, CAB was superior to vehicle in Black participants with acne and provided significantly greater reductions in both inflammatory and noninflammatory lesions. Acne lesion reductions were significantly greater with CAB compared to vehicle as early as Week 4. This early improvement is crucial, as early and effective treatment is key to preventing further development of acne sequelae, including hyperpigmentation.²⁵ Further, acne lesion reductions in Black participants are comparable to those observed in CAB-treated Hispanic participants, suggesting that CAB is efficacious across different racial and ethnic groups.²⁶

A potential concern with triple-combination therapy compared with dyads is the increased risk of adverse events from the addition of a third active ingredient. However, this analysis found that CAB was generally safe and well tolerated in Black participants, consistent with findings in the overall population of the primary Phase 2 and Phase 3 studies.^17,22,23 Further, rates of TEAEs with CAB treatment in Black participants were lower than in the overall study populations (20.5% vs. 24.6%–36.2%),^17,22 and no Black participants discontinued the study drug or study owing to TEAEs. CAB’s polymeric mesh formulation, which includes micronized BPO and adapalene designed to promote even distribution over the skin, might have contributed to its favorable tolerability profile.²² Additionally, the anti-inflammatory properties of clindamycin might have mitigated potential irritation typically associated with BPO and adapalene.^2,27–29

Drug tolerability is particularly pertinent for patients with skin of color, as adverse effects such as irritation can induce post-inflammatory hyperpigmentation, which can be more distressing to patients than the acne itself.^9,21 Further, a goal of acne treatment in patients with skin of color is to reduce acne-induced lesional hyperpigmentation without causing hypopigmentation in the surrounding skin.²⁵ Hyperpigmentation mean scores following CAB treatment remained at or below its baseline value (0.7), suggesting treatment with CAB did not exacerbate acne- or treatment-related dyspigmentation. Moreover, a higher percentage of CAB-treated versus vehicle-treated participants had hyperpigmentation ratings of “none” or “mild” at Week 12 (88.3% vs. 80.0%). This was despite comparable baseline values between CAB and vehicle groups (79.5% vs. 76.5%). Finally, CAB treatment was not associated with any trends in hypopigmentation, with a mean value of 0.1 at Week 12.

In addition to good efficacy and tolerability, improvement in quality of life is an important goal of acne therapy. In these studies, mean Acne-QoL domain scores at baseline were comparable between Black participants and the overall pooled population (range, 18.8–21.5 vs. 19.9–21.9). CAB treatment in Black participants led to increases (improvements) in all Acne-QoL domain scores, with significantly greater increases compared to vehicle for 3 out of 4 domains. The largest quality-of-life improvements associated with CAB treatment were in the self-perception and role-emotional domains.

Limitations. It is important that these findings are considered within the limitations of the primary studies and this post hoc analysis. First, the primary studies were not powered to detect significant differences between CAB and vehicle gel treatment in this post hoc analysis of Black participants; therefore, P values are provided for informative purposes only. Second, participants were not categorized based on Fitzpatrick skin types, but rather this post hoc analysis evaluated CAB gel in participants who self-identified as Black; however, racial self-identification does not necessarily reflect skin color or all skin characteristics.³⁰ Third, the total number of participants randomized to the CAB and vehicle arms who self-identified as Black was small (n=156); yet, the proportion of Black participants in the CAB studies (14%) is in keeping with census bureau estimates of the percentage of the US population identifying as Black or African American (13.7%).³¹ Finally, the 12-week duration of these CAB studies is likely not long enough to fully capture pigmentary changes following acne treatment in Black participants²⁵; however, as hyperpigmentation can improve over time without treatment, longer trials may conflate treatment effects with intrinsic improvements.¹³ Importantly, a recent systematic review of the efficacy and safety of current acne treatments in patients with skin of color found that out of 55 included studies, only four exclusively evaluated outcomes in patients with Fitzpatrick skin types IV to VI.³² Furthermore, studies on acne that incorporate the evaluation of pigmentation are uncommon.²⁵ Therefore, despite these limitations, the present analysis adds valuable information to the limited literature describing effects of acne therapies in Black individuals.

Conclusion

Fixed-dose, triple-combination CAB gel was well tolerated in Black participants with moderate to severe acne and led to substantial acne reductions. In two Phase 2 and two Phase 3 studies, 12-week CAB treatment in Black participants was associated with treatment success in nearly one-third of participants, nearly 70-percent reductions in inflammatory lesions, and nearly 60-percent reductions in noninflammatory lesions. Most treatment-emergent adverse events were mild to moderate in severity and no participants discontinued the study owing to adverse events. The favorable efficacy and safety profile of CAB demonstrates its potential as an effective treatment option for moderate to severe acne in Black individuals.

Acknowledgments

This study was funded by Ortho Dermatologics. Medical writing and editorial support were provided by Lacy Goode, PhD, and Kavitha Abiraman, PhD, from Prescott Medical Communications Group, a Citrus Health Group, Inc., company (Chicago, Illinois) with support from Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.

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