Recalcitrant Pediatric Facial Vitiligo Successfully Treated with Roflumilast Cream 0.3% Once Daily

J Clin Aesthet Dermatol. 2025;18(1):52–54.

by Kelly Warren, MD, and Sofia Sanchez, BA

Dr. Warren and Ms. Sanchez are with Derm Texas in Dallas, Texas.

FUNDING: Medical writing support was provided by Arcutis Biotherapeutics, Inc.

DISCLOSURES: The authors report no conflicts of interest relevant to the content of this article.

ABSTRACT: Vitiligo is an autoimmune disorder that causes melanocyte damage and pigment loss. The clinical presentation of vitiligo consists of patchy areas of lighter skin and results from a loss of functioning melanocytes and may be more visible in darker skin toned patients. Vitiligo affects approximately 2 percent of children and adolescents in the United States, with half of the affected cases undiagnosed. Pediatric patients are at a high risk of experiencing psychosocial adverse events such as depression and anxiety if the vitiligo is not quickly or effectively treated due primarily to the visual presentation of the disease. These adverse events may be seen especially in patients with a darker skin tone. Treatments for pediatric vitiligo in the past has usually included phototherapy, topical corticosteroids, vitamin D and calcineurin inhibitors; topical ruxolitinib has been approved more recently for nonsegmental vitiligo in patients 12 years of age and older. In cases where disease is recalcitrant, the need for additional therapies is warranted. Roflumilast cream 0.3% is a highly selective, non-steroidal and potent topical phosphodiesterase 4 inhibitor approved in 2022 by the United States Food and Drug Administration for the treatment of psoriasis, in 2023 as a foam for the treatment of seborrheic dermatitis and in 2024, roflumilast cream 0.15% was approved for the treatment of atopic dermatitis, including in children down to six years of age. Topical roflumilast is well tolerated with a favorable safety profile among pediatric dermatology populations. We describe four cases of pediatric skin of color patients with facial vitiligo that were refractory to topical corticosteroids, ruxolitinib and phototherapy. All patients were started on roflumilast cream 0.3% once daily and demonstrated improvement in repigmentation.

Keywords: Vitiligo, roflumilast cream, pediatric vitiligo, topical therapies for vitiligo

Vitiligo is a cutaneous autoimmune disorder, caused by damage or destruction to melanocytes and a clinical presentation of hypopigmentation or depigmentation occurring in typical patterns.¹ The pediatric prevalence is up to approximately two percent and the condition often is associated with a significant psychosocial burden, including depression and anxiety, particularly among patients with darker skin tone due to the more noticeable appearance of the condition.^1–5 Vitiligo is typically progressive and early intervention is shown to be crucial for improving outcomes and quality of life for affected children and adolescents.¹ Treatments for pediatric vitiligo include phototherapy, topical corticosteroids, vitamin D, calcineurin inhibitors and among patients 12 years and older, topical ruxolitinib.² In cases where disease is recalcitrant, despite attempting these treatments, the need for emerging therapeutic approaches is warranted. 

Topical roflumilast is a selective and potent topical phosphodiesterase 4 (PDE4) inhibitor that is not a corticosteroid and is approved to treat atopic dermatitis (AD), seborrheic dermatitis, and plaque psoriasis.^6–9 PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators, especially when overexpressed in specific disease states.^6,7 Roflumilast cream 0.3% is approved in the United States (US) for the treatment of plaque psoriasis, including intertriginous areas, in patients six years of age and older and also is approved as a 0.15% cream in the US for the treatment of AD in patients six years of age and older.⁸ Roflumilast foam 0.3% is approved in the US for the treatment of seborrheic dermatitis in adults and children nine years of age and older. PDE4 enzymes may play a role in the inflammatory pathways involved in the pathogenesis of vitiligo, with modulation of key cytokines associated with vitiligo.¹⁰ A few case studies have shown modest effectiveness of topical crisaborole 2% ointment in the treatment of vitiligo, and the effectiveness of oral PDE4 inhibitors has been inconsistent.^10,11 Based on in vitro data, roflumilast was shown to be highly selective in inhibiting PDE4 isoenzymes, and was a more potent inhibitor of PDE4 than other tested agents, including crisaborole and apremilast.^6,7 In this case series we identified four pediatric skin of color patients with facial vitiligo who were refractory to topical corticosteroids, topical ruxolitinib, and phototherapy. Patients were treated with roflumilast cream 0.3% applied once daily to the face resulting in at least partial skin repigmentation in all cases. Proper informed consent was obtained for photography in all four cases including for their use in publications that will be distributed publically. 

Case series. Case 1. A five-year-old Hispanic male patient presented with a one-year history of vitiligo affecting his nose, upper lip, cheeks, elbows, abdomen, legs, and knees. Prior therapy with triamcinolone cream, applied twice daily for six months, yielded no clinical improvement. The patient was evaluated and initiated on a regimen of once-daily application of roflumilast cream 0.3% to the affected areas of the face only. After three months of treatment, the patient returned to the clinic, showing significant improvement in the treated areas. The patient’s mother was advised to continue applying roflumilast cream 0.3% once daily to the face. Six weeks later, the patient returned, demonstrating near-complete resolution of the vitiligo on the nose and upper lip. The patient will continue the once-daily application of topical roflumilast to the affected facial areas, with follow-up clinic visits scheduled every six months. No adverse reactions were noted.

Case 2. A 13-year-old Hispanic female patient with vitiligo since age seven years presented to the clinic with depigmentation to her face, ears, wrist, elbows, knees, feet and ankles. Prior therapy consisted of laser (Xtrac®; Strata Skin Sciences) three times per week for one year, without improvement. The patient’s mother reported that she was previously treated with a topical drug (unknown) but it was not effective. Upon initial presentation, patient was initiated with a trial of roflumilast cream 0.3% once daily to affected areas of the face only. She returned after six weeks of treatment and showed limited improvement. The patient was instructed to continue with once daily treatment to affected areas of the face only. Patient returned to the clinic two months later and demonstrated improvement on the affected areas of her face. Patient will continue treatment with once daily application with regular follow up. No adverse reactions were noted.

Case 3. A six-year-old Hispanic female patient presented with a history of vitiligo from age three years on the right side of her face and no prior topical therapy. Patient presented for treatment and management of vitiligo; treatment was initiated treatment with clobetasol ointment 0.05% twice daily for two weeks to the face. After one week, the patient demonstrated no improvement. Treatment was modified to add imiquimod cream applied daily each morning in addition to clobetasol every other day. Patient returned for evaluation at the four-week follow up visit and clinical evaluation showed no changes to vitiligo, but the patient was advised to continue therapy for an additional month. At the subsequent visit, eight weeks later, the patient continued to be unresponsive to the treatment regimen. Patient was started on ruxolitinib cream 1.5% twice daily and clobetasol every other day. Patient returned after approximately six weeks of treatment and demonstrated no significant improvement. Patient continued with ruxolitinib cream twice daily for an additional six weeks and at follow-up did not show any improvement or changes to vitiligo. At this point her therapy was changed to desonide 0.05% cream to be applied once daily with a follow-up visit in approximately one month. Upon evaluation in the clinic on following four weeks of treatment, no improvement or changes were noted, and therapy was changed to calcipotriene and betamethasone cream applied once daily. At the subsequent visit, following eight weeks of treatment, the patient showed very little improvement and all treatments were discontinued and the patient was switched to roflumilast cream 0.3% monotherapy to be applied once a day. After eight weeks of treatment, the patient returned and showed some facial skin repigmentation. The patient continued with once daily roflumilast cream 0.3% and after three months of treatment the patient continued to show areas of repigmentation. Patient’s mother was advised to continue treatment with topical roflumilast application once daily. After more than six months of treatment, the patient returned to the clinic showing dramatic improvement and was advised to continue with her roflumilast cream 0.3% once daily regimen until further evaluation. No adverse reactions were noted.

Case 4. An 11-year-old Indian male patient presented with a single patch of vitiligo on the left side of the mouth which developed a few months prior to initial clinic visit. Prior treatment consisted of hydrocortisone 2.5% twice daily for two weeks without improvement. At initial visit, patient was started on ruxolitinib cream 1.5% twice daily. Patient returned for evaluation after approximately six weeks and did not demonstrate any clinical improvement at which point treatment with topical ruxolitinib was continued for an additional month. Evaluation after five months of topical ruxolitinib treatment also showed no improvement in the patients’ vitiligo. Topical ruxolitinib therapy was stopped and the patient was started on roflumilast cream 0.3% once daily. Patient returned after 10 weeks of treatment and demonstrated approximately 90 percent repigmentation of his vitiligo patch. Patient continued on roflumilast cream 0.3% and will return for regular evaluation. No adverse reactions were noted.

Discussion

This case series suggests that roflumilast cream 0.3% may have a positive therapeutic effect in pediatric patients with facial vitiligo who are unresponsive to other therapies. Roflumilast cream is a particularly attractive treatment option for this pediatric population due to its local tolerability and safety profile among other pediatric dermatology populations treated for AD, plaque psoriasis, and seborrheic dermatitis, all with FDA-approval. Additional trials are necessary to evaluate the efficacy and safety of roflumilast cream 0.3% in the treatment of vitiligo on the face and for other affected anatomic locations.

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