{"id":"roflumilast-foam","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site irritation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"By inhibiting PDE-4, roflumilast prevents the breakdown of cyclic adenosine monophosphate (cAMP), leading to elevated cAMP levels in macrophages, neutrophils, and other inflammatory cells. This suppresses the production of pro-inflammatory cytokines and chemokines, reducing overall inflammatory responses. The foam formulation is designed for topical delivery to affected skin areas in inflammatory dermatological conditions.","oneSentence":"Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammation by increasing intracellular cAMP levels in immune and inflammatory cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:32:37.225Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis (topical foam formulation)"},{"name":"Plaque psoriasis (topical foam formulation)"}]},"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":"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":"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":"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":"NCT04128007","phase":"PHASE2","title":"Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2020-01-13","conditions":"Plaque Psoriasis","enrollment":304}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":10,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ARQ-154"],"phase":"phase_3","status":"active","brandName":"Roflumilast Foam","genericName":"Roflumilast Foam","companyName":"Arcutis Biotherapeutics, Inc.","companyId":"arcutis-biotherapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Roflumilast Foam 0.3% is being studied as a potential treatment for various skin conditions, including Non-segmental Vitiligo, Scalp Psoriasis, Seborrheic Dermatitis, Hidradenitis Suppurativa, and Plaque Psoriasis. The foam is a topical formulation of the medication Roflumilast, which is applied directly to the skin to treat these conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}