{"id":"roflumilast-cream-0-05","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site irritation"},{"rate":null,"effect":"Application site burning"},{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Erythema"}]},"_chembl":null,"_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 in the skin. The topical cream formulation delivers the drug directly to affected skin areas while minimizing systemic exposure.","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":"2026-03-28T01:32:37.198Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis (topical)"},{"name":"Plaque psoriasis (topical)"}]},"trialDetails":[{"nctId":"NCT04804605","phase":"PHASE3","title":"Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2021-02-25","conditions":"Atopic Dermatitis Eczema","enrollment":1220},{"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":"NCT06998056","phase":"PHASE2","title":"Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis","status":"COMPLETED","sponsor":"Arcutis Biotherapeutics, Inc.","startDate":"2025-06-09","conditions":"Atopic Dermatitis (Eczema)","enrollment":101},{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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"],"phase":"phase_3","status":"active","brandName":"Roflumilast Cream 0.05%","genericName":"Roflumilast Cream 0.05%","companyName":"Arcutis Biotherapeutics, Inc.","companyId":"arcutis-biotherapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells. Used for Atopic dermatitis (topical), Plaque psoriasis (topical).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}