title: A bilateral comparison study of pimecrolimus cream 1% and a topical medical device cream in the treatment of patients with atopic dermatitis.
abstract: Corticosteroids are the mainstay of therapy for atopic dermatitis, but long-term use is associated with adverse effects. We sought to evaluate the clinical efficacy of two steroid-sparing creams for atopic dermatitis. Twenty patients were enrolled in an investigator-blinded, bilateral comparison study. Patients applied pimecrolimus cream twice daily to a target lesion on one side of the body and also applied a topical medical device cream three times daily on a symmetrical target lesion on the opposite side of the body for four weeks. Clinical assessments including Physician Global Assessment (PGA), Target Lesion Symptom Score (TLSS), subject self-assessment and digital photography were performed at the baseline, 2 week, and 4 week visits. Seventy-five percent of patients (pimecrolimus, 15 of 20; topical medical device, 15 of 20) were rated "clear" (0) or "almost clear" (1) by PGA for both medications after four weeks. Percent improvement of the PGA from randomization for pimecrolimus cream and the topical medical device cream were 72.50 and 71.67 respectively (P=0.9283). PGA scores decreased significantly from baseline for both treatments (P=0.004). Overall, there was no statistically significant difference between treatment groups for PGA scores throughout the study (P=0.8236). No cutaneous side effects were noted. Our study was limited by a small sample size and lack of double-blinding; however, both treatments were found to be safe and effective in treating atopic dermatitis over four weeks. Significant improvements were noted for all efficacy variables. In conclusion, a lipid-rich, non-steroidal, topical medical device cream was as effective in improving atopic dermatitis as pimecrolimus cream.
authors: Mount Sinai School of Medicine, Department of Dermatology, New York, NY 10029, USA. jason.emer@mssm.edu
authors: Jason J
authors: JJ
authors: Emer
authors: Amylynne
authors: A
authors: Frankel
authors: Andrew
authors: A
authors: Sohn
authors: Mark
authors: M
authors: Lebwohl
mesh_terms: D000279:Administration, Cutaneous; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002592:Cetomacrogol / Q000009:adverse effects / Q000494:pharmacology*; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008899:Mineral Oil / Q000009:adverse effects / Q000494:pharmacology*; D010577:Petrolatum / Q000009:adverse effects / Q000494:pharmacology*; D016037:Single-Blind Method; D016559:Tacrolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D004338:Drug Combinations; D005233:Fatty Alcohols; C567979:cetomacrogol, cetostearyl alcohol, mineral oil, petrolatum drug combination; C117268:pimecrolimus; D010577:Petrolatum; D008899:Mineral Oil; D002592:Cetomacrogol; D016559:Tacrolimus