Real-World Use of Tapinarof Cream 1% Once Daily in Patients with Seborrheic Dermatitis: A Case Series

J Clin Aesthet Dermatol. 2025;18(1):24–28.

by Naiem T. Issa, MD, PhD, and Lidia Pomaville, PA-C, MPAS 

Dr. Issa is with Forefront Dermatology in Vienna, Virginia; Issa Research and Consulting, LLC in Springfield, Virginia; the University of Miami Leonard M. Miller School of Medicine in Miami, Florida; and the George Washington University School of Medicine and Health Sciences in Washington, District of Columbia. Ms. Pomaville is with Forefront Dermatology in Berwyn, Illinois; the Marquette University College of Health Sciences, PA Studies Program in Milwaukee, Wisconsin; and the University of Dubuque, MSPAS Program, in Dubuque, Iowa.

FUNDING: Research and editorial support for this case series was funded by Dermavant Sciences, Inc.  

DISCLOSURES: Dr. Issa has served as an advisor, consultant, speaker, or investigator for Dermavant Sciences, Inc.; Dr. Pomaville reports no relevant conflicts of interest.

ABSTRACT: Seborrheic dermatitis (SD) is an inflammatory skin disease with multifactorial etiology, involving genetic and environmental factors. Many conventional therapies for SD (ie, topical antifungals, topical corticosteroids) are associated with incomplete efficacy, frequent and sometimes rapid disease recurrence, and restrictions on duration of therapy and anatomic sites of application. This may be because they cannot target multiple disease processes and/or are limited by safety considerations. Topical roflumilast foam was approved for the treatment of SD in 2023, but additional options are needed. The pathophysiology of atopic dermatitis (AD) and psoriasis have similarities with SD, supporting the hypothesis that tapinarof cream 1% once daily (QD) may be beneficial and well tolerated for patients with SD. Tapinarof is a non-steroidal, topical aryl hydrocarbon receptor agonist approved for the treatment of plaque psoriasis in adults. Tapinarof downregulates pro-inflammatory cytokines implicated in AD and plaque psoriasis, restores the skin barrier through upregulation of skin barrier components, and reduces oxidative stress. Here, we report that tapinarof cream 1% QD used for the treatment of four adults with mild-to-severe SD affecting the face, neck, back, and chest, demonstrated a rapid onset of efficacy and noticeable improvements in disease activity. Efficacy was maintained after treatment discontinuation, indicating a possible remittive effect as previously described in plaque psoriasis. The efficacy and potential remittive effect may be attributed to the unique mechanism of action and clinical profile of tapinarof cream. Tapinarof is a novel topical therapy that may be beneficial for patients with SD.

Keywords: Seborrheic dermatitis, case series, tapinarof cream 1% once daily, aryl hydrocarbon receptor agonist, plaque psoriasis 

Introduction

Seborrheic dermatitis (SD) is a chronic, recurrent, inflammatory skin condition characterized by the development of pruritic, erythematous patches with easily detachable, yellow-grey scaling.¹ SD mostly affects sebum-rich areas, such as the scalp, face, upper chest, and back, and can have a negative impact on health-related quality of life (HRQoL) due to itching, pain, irritation, and/or dryness, and feelings of embarrassment, anxiety, and decreased self-esteem during flares.^1–3 As SD frequently occurs on the face and other visible areas, it may be psychosocially stigmatizing, with a consequent substantial impact on quality of life.⁴ SD is burdensome and prevalent, affecting at least 1 to 3 percent of the general population in the United States (US), 70 percent of infants in the first three months of life, and 3 to 5 percent of adolescents.^1,5 SD is also highly prevalent (34–83%) in individuals who are immunocompromised, including patients on immunosuppressive therapy (eg, organ transplant recipients, people with cancer), suggesting an immunologic component, and in patients with neurologic disorders, such as Parkinson’s disease.^4,6 

The etiology of SD is not fully understood; however, the pathophysiology is considered to involve both genetic and environmental factors.^7–9 SD is associated with dysregulation of normal skin immunologic function, dysfunction of epidermal barrier and lipid composition, changes in the skin microbiome (ie, dysbiosis), and individual susceptibility to inflammatory responses.^7,8 Anatomic sites with a high density of sebaceous glands are associated with changes in skin commensal microbiota, including increased growth of the Malassezia yeast species, which has been associated with the development of SD.⁹ However, while Malassezia spp. may play an integral role in the pathophysiology of SD, reduction in Malassezia spp. alone does not effectively improve symptoms, and other factors are involved.⁸ The inflammatory responses in SD include the release of pro-inflammatory cytokines (interleukin [IL]-17, IL-1α, IL-2, interferon [IFN]-γ), resulting in keratinocyte proliferation and stratum corneum thickening, inflammation, and skin barrier dysfunction.⁹ Genomic and immunologic molecular profiling has identified that SD has a unique clinical presentation and pathophysiology;¹⁰ consequently, there is partial overlap in the clinical presentation and pathophysiology of SD with both atopic dermatitis (AD) and psoriasis. 

There is no cure for SD, and conventional current therapies (eg, antifungals, topical corticosteroids, and calcineurin inhibitor immunomodulators) focus on alleviating symptoms, preventing flares, and maintaining a treatment response to limit relapses.^1,11  Treatment selection is based on patient age, disease severity, history, and presentation, including sites of involvement, as well as previous response to therapy.¹¹ Topical antifungals and/or low-to-mid potency topical corticosteroids have been used as both initial and intermittently repeated treatments, with specific formulation selected depending on sites affected.^9,11 As a result, many patients use more than one product to treat their SD.  

Recurrence of SD and incomplete efficacy with current therapies may be because these treatments do not target the multiple pathophysiologic drivers of the disease process.¹¹ As a result, treatment rotation of various therapies and frequent need for different formulations to treat various anatomic sites may be more effective than monotherapy, but is burdensome and confusing for patients, especially over time.¹¹ Topical roflumilast foam was approved in 2023 for the treatment of SD;¹² however, it is important for clinicians to have additional options, especially for common skin disorders that are recurrent and require long-term management.

Tapinarof (VTAMA®; Dermavant Sciences, Inc.) cream 1% once daily (QD) is a non-steroidal, topical aryl hydrocarbon receptor (AhR) agonist approved by the US Food and Drug Administration for the treatment of plaque psoriasis in adults and is currently being evaluated for the treatment of AD in adults and children down to two years of age.^13,14  Tapinarof binds to and activates AhR to downregulate pro-inflammatory cytokines that are implicated in AD (eg, IL-4, IL-5, IL-13, and IL-31) and psoriasis (eg, IL-17A, IL-17F, and IFN-γ).^15,16 Tapinarof has also been shown to restore the skin barrier through upregulation of skin barrier components, including filaggrin, loricrin, hornerin, involucrin, and ceramide lipids, as well as reduce oxidative stress in the skin.^15,16 The underlying disease mechanism of AD and psoriasis have some overlap with SD, and the mechanism of action described supports the therapeutic potential of topical tapinarof for SD. In a previously reported case, off-label topical treatment with tapinarof cream 1% QD reduced itch and decreased the need for frequent re-treatment in a patient with SD, highlighting its potential therapeutic utility.³ Here, we report real-world use of tapinarof cream 1% once daily for the treatment of SD in four adult patients. All patients provided informed consent and photographic release. 

Case Series 

Case 1. This 35-year-old White male patient with Fitzpatrick Skin Type (FST) II had a history of intermittent SD recurrence of more than 15 years affecting the face and chest. Previous treatments included over-the-counter moisturizers, intermittent low- and medium-potency topical steroids, and daily use of emollients to alleviate SD symptoms, which resulted in intermittent or partial resolution of symptoms. The patient had not used topical antifungals to manage SD. 

At baseline, the patient presented with mild SD (Investigator’s Global Assessment [IGA]=2) on the face (Figure 1A), with inflamed skin, scaly patches, itchiness, dryness, and flaking that had been ongoing for one month. He was prescribed tapinarof cream 1% once daily and applied a thin layer to the affected skin for 20 days. Almost complete skin clearing (IGA=1; no photo available) was observed after seven days of treatment with tapinarof. Almost clear skin was maintained at Day 20, with visibly less erythema (Figure 1B). The patient continued to use tapinarof cream 1% once daily until clearance was achieved at 56 days when treatment was discontinued. Tapinarof was restarted when a flare reoccurred approximately two weeks after stopping treatment, which resolved in less than seven days. The patient experienced no adverse effects.

Case 2. A 29-year-old White male patient with FST II had a five-year history of intermittent SD. The most recent relapse of SD had been present for one month. The patient had never sought treatment from a clinician prior to this visit, and previous self-treatments included over-the-counter moisturizers and the daily use of emollients. 

At baseline, the patient had moderate SD (IGA=3) on the face, with inflamed skin, scaly patches, itchiness, dryness, and flaking (Figure 2A). The patient was instructed to apply a thin layer of tapinarof cream 1% once daily to the affected areas of the skin until complete clearance. Complete clearance was achieved (IGA=0) after six days of treatment with tapinarof cream 1% once daily, and therapy was discontinued (Figure 2B). The patient reported no adverse effects during treatment but was lost to follow-up thereafter.

Case 3. A 36-year-old White male patient with FST II had a 10-year history of SD. At presentation, the patient reported a Worst Itch Numeric Rating Scale score of 6 on a scale of 0 (no itch) to 10 (worst imaginable itch). The current episode of SD had been present for six months. Previous treatments included several courses of topical antifungals, including ketoconazole and clotrimazole, and corticosteroids, including hydrocortisone, desonide, and triamcinolone. Treatment courses had provided intermittent relief, but the patient experienced frequent flares of scaling, erythema, and itch. The patient expressed an interest in non-steroidal topical treatment, given concerns for adverse effects and the desire to avoid systemic therapies.

At baseline, the patient presented with severe SD (IGA=4) on the face, neck, and chest (Figure 3A), with scaly patches, inflamed skin, itchiness, dryness, and flaking. Following once-daily treatment with tapinarof cream 1% for 30 days, the patient achieved almost clear skin (IGA=1) and discontinued therapy (Figure 3B). In accordance with local care procedures, he was monitored for a possible remittive effect (defined as maintenance of an IGA score of 0 [clear] or 1 [almost clear] after first achieving an IGA score of 0). The image at Day 60 (after 30 days completely off therapy) shows almost clear skin with reduced inflammation (Figure 3C). No adverse effects were reported by the patient.

Case 4. A 55-year-old Hispanic female patient with FST III was formally diagnosed with SD approximately three months prior to the current presentation. Prior to formal diagnosis, the patient reported intermittent symptoms associated with SD on the face for approximately one year. Previous treatments included a prescription non-steroidal, anti-inflammatory/antifungal, water-based emulsion cream daily for one month, a non-prescription colloidal sulfur and salicylic acid cleanser twice daily for two months, and alclometasone dipropionate 0.05% corticosteroid cream twice daily for two weeks. The patient had used various emollients and changed their cosmetics brands and cleansers in various attempts to alleviate the symptoms; however, no improvements were observed from self-care or from the use of prior prescription therapy. 

At baseline, the symptoms that had previously been localized to the face were now also affecting the neck, chest, and upper back. The patient presented with mild SD (IGA=2) on the face, neck, upper back, and chest (Figure 4A), with scaly patches, inflamed skin, itchiness, dryness, and flaking. The patient was instructed to apply a thin layer of tapinarof cream 1% once daily to the affected skin. Complete clearance was achieved (IGA=0; no photo available) after nine days of treatment with once-daily tapinarof cream, and therapy was discontinued. Figures 4B–D shows completely clear skin was maintained off treatment after 2, 11, and 13 months, respectively, indicating a possible remittive effect.

Discussion

In this case series, tapinarof cream 1% once daily demonstrated efficacy and noticeable improvement in disease activity in patients with mild to severe SD on the face, neck, back, and chest. To date, tapinarof cream 1% once daily has demonstrated significant efficacy and was well tolerated in Phase III clinical trials in patients with AD and plaque psoriasis.^13,17,18 Tapinarof has also demonstrated favorable tolerability and minimal-to-no systemic exposure when used in patients with plaque psoriasis or AD, even in children down to two years of age with AD and in patients with extensive disease.^13,17–20

In these real-world cases, patients with SD treated with once-daily topical tapinarof cream rapidly achieved completely clear (IGA=0) or almost clear (IGA=1) skin within 6 to 9 days of treatment, with visible reduction in disease activity (Cases 1, 2, and 4). Clear skin was also observed when tapinarof cream was used to treat symptoms that recurred after stopping treatment (Case 1). Furthermore, it appears that tapinarof cream may exhibit a potential remittive effect upon discontinuation of treatment (Cases 3 and 4).

There is overlap in the clinical presentation and pathology of SD and both AD and psoriasis. The pathophysiology of SD, AD, and psoriasis involves upregulation of pro-inflammatory cytokines, disruption of structural epidermal biomarkers and ceramides, which are important for skin barrier integrity; and an increase in oxidative stress.^{7,10,15, 21–23}

The rapid skin clearing observed could be attributed to the ability of tapinarof cream to downregulate pro-inflammatory Th17 cytokines (IL-17A, IL-17F, and IFN-γ), restore the skin barrier through upregulation of skin barrier components, and reduce oxidative stress in the skin, both through direct free radical scavenging and via the nuclear factor erythroid 2-related factor 2 pathway.^{15,16, 21} Tapinarof has been shown to inhibit the generation, persistence, and cytokine production of resident memory T cells in the skin.²⁴ The potential remittive effect observed after discontinuation of tapinarof therapy in Cases 3 and 4 may be explained by a similar mechanism described by Mooney et al.²⁴

Conclusion

Tapinarof is a novel topical therapy approved for treatment of mild to severe plaque psoriasis in adults, with no restrictions regarding duration of use, application sites, or extent of body surface area affected. It is being evaluated by the US Food and Drug Administration for the treatment of AD in adults and children as young as two years of age. As the underlying disease mechanism of AD and psoriasis partially overlap with SD, the clinical outcomes from this small case series suggest that the non-steroidal, topical AhR agonist, tapinarof, may be beneficial for patients with SD, warranting further investigation.

Acknowledgements

Medical writing and editorial support, under the guidance of the authors, was provided by ApotheCom, UK, in accordance with Good Publication Practice. 

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