{"id":"topical-roflumilast","safety":{"commonSideEffects":[{"rate":"null","effect":"Application site reactions"},{"rate":"null","effect":"Headache"},{"rate":"null","effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By inhibiting phosphodiesterase 4, roflumilast decreases the production of pro-inflammatory cytokines, leading to reduced inflammation in the skin. This mechanism is particularly useful for treating inflammatory skin conditions such as psoriasis.","oneSentence":"Topical roflumilast is a phosphodiesterase 4 inhibitor that reduces inflammation in the skin.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:39:25.240Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe plaque psoriasis"}]},"trialDetails":[{"nctId":"NCT07263230","phase":"PHASE2","title":"The Safety and Efficacy of Roflumilast Foam in HS","status":"RECRUITING","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2026-04-01","conditions":"Hidradenitis Suppurativa (HS)","enrollment":20},{"nctId":"NCT07077902","phase":"PHASE2","title":"A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa","status":"RECRUITING","sponsor":"Tulane University","startDate":"2025-09-25","conditions":"Hidradenitis Suppurativa","enrollment":10},{"nctId":"NCT04845620","phase":"PHASE3","title":"Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2021-04-07","conditions":"Atopic Dermatitis Eczema","enrollment":652},{"nctId":"NCT07105254","phase":"PHASE2","title":"An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)","status":"RECRUITING","sponsor":"Derm Texas, PLLC","startDate":"2025-08-01","conditions":"Non-segmental Vitiligo","enrollment":20},{"nctId":"NCT05028582","phase":"PHASE3","title":"Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2021-08-24","conditions":"Scalp Psoriasis","enrollment":432},{"nctId":"NCT06648772","phase":"PHASE3","title":"Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study","status":"RECRUITING","sponsor":"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","startDate":"2024-11-14","conditions":"Plaque Psoriasis","enrollment":189},{"nctId":"NCT04286607","phase":"PHASE3","title":"Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2020-02-12","conditions":"Chronic Plaque Psoriasis","enrollment":333},{"nctId":"NCT04773600","phase":"PHASE3","title":"Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2021-02-24","conditions":"Atopic Dermatitis Eczema","enrollment":683},{"nctId":"NCT06440473","phase":"PHASE4","title":"Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin","status":"RECRUITING","sponsor":"Rao Dermatology","startDate":"2024-05-28","conditions":"Healthy Skin","enrollment":3},{"nctId":"NCT04973228","phase":"PHASE3","title":"Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2021-07-08","conditions":"Seborrheic Dermatitis","enrollment":457},{"nctId":"NCT04655313","phase":"PHASE2","title":"Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2020-11-30","conditions":"Psoriasis, Plaque Psoriasis","enrollment":20},{"nctId":"NCT04091646","phase":"PHASE2","title":"Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2019-12-04","conditions":"Seborrheic Dermatitis","enrollment":226},{"nctId":"NCT05278624","phase":"PHASE2","title":"Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea","status":"COMPLETED","sponsor":"Dermatology Consulting Services, PLLC","startDate":"2022-04-15","conditions":"Rosacea","enrollment":40},{"nctId":"NCT04746911","phase":"PHASE2","title":"Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2021-03-01","conditions":"Psoriasis, Plaque Psoriasis","enrollment":10},{"nctId":"NCT03916081","phase":"PHASE2","title":"Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2019-05-31","conditions":"Atopic Dermatitis","enrollment":136},{"nctId":"NCT04211363","phase":"PHASE3","title":"Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2019-12-20","conditions":"Chronic Plaque Psoriasis","enrollment":439},{"nctId":"NCT03764475","phase":"PHASE2","title":"Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2018-12-18","conditions":"Plaque Psoriasis","enrollment":332},{"nctId":"NCT01856764","phase":"PHASE2","title":"Topical Roflumilast in Adults With Atopic Dermatitis","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2013-06","conditions":"Atopic Dermatitis","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":33,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ARQ-151 Cream 0.3%"],"phase":"phase_3","status":"active","brandName":"Topical roflumilast","genericName":"Topical roflumilast","companyName":"Arcutis Biotherapeutics, Inc.","companyId":"arcutis-biotherapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Roflumilast is a small molecule phosphodiesterase 4 inhibitor used in topical form to treat various skin conditions, including atopic dermatitis, flexural psoriasis, and seborrheic dermatatitis. It is available as a 0.05% cream and has been studied in clinical trials for its safety and efficacy in comparison to vehicle cream and methotrexate.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}