{"id":"roflumilast-foam-0-3","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site irritation"},{"rate":null,"effect":"Application site burning"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL193240","moleculeType":"Small molecule","molecularWeight":"403.21"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"By inhibiting PDE-4, roflumilast prevents the breakdown of cyclic adenosine monophosphate (cAMP) in inflammatory cells such as macrophages and T cells, leading to decreased production of pro-inflammatory cytokines and chemokines. This mechanism reduces skin inflammation and is particularly effective in conditions characterized by excessive immune activation. The foam formulation allows for topical delivery to affected skin areas.","oneSentence":"Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:32:34.672Z","_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":5,"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","ARQ-154 0.3%"],"phase":"phase_3","status":"active","brandName":"Roflumilast Foam 0.3%","genericName":"Roflumilast Foam 0.3%","companyName":"Arcutis Biotherapeutics, Inc.","companyId":"arcutis-biotherapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Roflumilast Foam 0.3% is being studied for its potential efficacy in treating Non-segmental Vitiligo, Scalp Psoriasis, Seborrheic Dermatitis, Hidradenitis Suppurativa, and Plaque Psoriasis. The exact mechanism of action of Roflumilast Foam 0.3% is not specified in the provided information, but according to ChEMBL, Roflumilast is a phosphodiesterase 4 inhibitor.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":3,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}