{"id":"placebo-of-pimecrolimus-cream-1","safety":{"commonSideEffects":[{"rate":null,"effect":"Adverse events expected to be similar to vehicle/excipient effects only"}]},"_chembl":{"chemblId":"CHEMBL1200686","moleculeType":"Small molecule","molecularWeight":"810.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a placebo of pimecrolimus cream, this product contains no active ingredient and serves as a control comparator in clinical trials. Pimecrolimus itself is a calcineurin inhibitor that would suppress T-cell activation, but the placebo formulation is inert and produces only non-specific effects.","oneSentence":"This is a placebo formulation with no active pharmacological mechanism.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:28:11.986Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control arm in phase 3 clinical trials for atopic dermatitis or other inflammatory skin conditions"}]},"trialDetails":[{"nctId":"NCT06241118","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor","status":"RECRUITING","sponsor":"Sanofi","startDate":"2024-02-29","conditions":"Dermatitis Atopic","enrollment":390},{"nctId":"NCT05729074","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients","status":"UNKNOWN","sponsor":"HK inno.N Corporation","startDate":"2023-02-13","conditions":"Mild to Moderate Atopic Dermatitis","enrollment":80},{"nctId":"NCT03107611","phase":"PHASE3","title":"Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2016-02-29","conditions":"Atopic Dermatitis","enrollment":654},{"nctId":"NCT00128245","phase":"PHASE2","title":"Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-09","conditions":"Keratoconjunctivitis Sicca","enrollment":440},{"nctId":"NCT02896101","phase":"PHASE3","title":"Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Glenmark Pharmaceuticals Ltd. India","startDate":"2016-08","conditions":"Atopic Dermatitis","enrollment":755},{"nctId":"NCT03834935","phase":"PHASE2, PHASE3","title":"Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba","status":"UNKNOWN","sponsor":"St Joseph University, Beirut, Lebanon","startDate":"2019-03-01","conditions":"Pityriasis Alba","enrollment":40},{"nctId":"NCT03297502","phase":"PHASE3","title":"Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2016-06","conditions":"Atopic Dermatitis","enrollment":582},{"nctId":"NCT01692626","phase":"PHASE2","title":"1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX","status":"TERMINATED","sponsor":"West Virginia University","startDate":"2012-02","conditions":"Rash","enrollment":13},{"nctId":"NCT00655512","phase":"PHASE1","title":"Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound","status":"COMPLETED","sponsor":"Technische Universität Dresden","startDate":"2008-01","conditions":"Healthy","enrollment":40},{"nctId":"NCT00297037","phase":"PHASE2","title":"Pimecrolimus Cream for Oral Lichen Planus","status":"COMPLETED","sponsor":"University of Utah","startDate":"2005-08","conditions":"Oral Lichen Planus","enrollment":21},{"nctId":"NCT00119158","phase":"PHASE4","title":"Combination Therapy for Atopic Dermatitis","status":"COMPLETED","sponsor":"Children's Hospital of Philadelphia","startDate":"2004-10","conditions":"Atopic Dermatitis","enrollment":90},{"nctId":"NCT00810862","phase":"PHASE4","title":"Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children","status":"TERMINATED","sponsor":"Children's Hospital of Michigan","startDate":"2006-11","conditions":"Atopic Dermatitis","enrollment":18},{"nctId":"NCT00139581","phase":"PHASE4","title":"Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-09","conditions":"Atopic Dermatitis","enrollment":""},{"nctId":"NCT00226707","phase":"PHASE3","title":"Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-07","conditions":"Chronic Hand Dermatitis","enrollment":652},{"nctId":"NCT00351052","phase":"PHASE3","title":"Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Novartis","startDate":"2001-12","conditions":"Atopic Dermatitis","enrollment":184},{"nctId":"NCT00120302","phase":"PHASE4","title":"Quality of Life Study in Adults With Facial Eczema","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-03","conditions":"Atopic Dermatitis","enrollment":76},{"nctId":"NCT00130364","phase":"PHASE4","title":"Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-08","conditions":"Atopic Dermatitis","enrollment":200},{"nctId":"NCT00121381","phase":"PHASE4","title":"Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-05","conditions":"Dermatitis, Atopic","enrollment":400},{"nctId":"NCT00121316","phase":"PHASE4","title":"Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-10","conditions":"Atopic Dermatitis","enrollment":200},{"nctId":"NCT00117377","phase":"PHASE4","title":"Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-04","conditions":"Atopic Dermatitis","enrollment":70}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Placebo of Pimecrolimus Cream, 1%","genericName":"Placebo of Pimecrolimus Cream, 1%","companyName":"Glenmark Pharmaceuticals Ltd. India","companyId":"glenmark-pharmaceuticals-ltd-india","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This is a placebo formulation with no active pharmacological mechanism. Used for Control arm in phase 3 clinical trials for atopic dermatitis or other inflammatory skin conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}