Hydrocortisone butyrate 0.1% lipocream in pediatric patients with atopic dermatitis.

Author(s): Abramovits W, Oquendo M

Affiliation(s): Department of Medicine, Baylor University Medical Center, Dallas, TX 75230, USA. dra@dermcenter.us

Publication date & source: 2010-03, Skinmed., 8(2):72-9.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

Only a few corticosteroids for topical use have proven safe and effective in pediatric populations down to 3 months of age. The authors report the results of a study designed to assess the efficacy and safety of hydrocortisone butyrate (HCB) 0.1% in lipocream (LCr) vehicle in infants and children. A total of 264 boys and girls 3 months to less than 18 years old, with stable, mild to moderate atopic dermatitis affecting at least 10% body surface area applied HCB 0.1% in LCr or LCr alone twice daily for up to 1 month without occlusion. Primary end-points included: percent of patients who achieved treatment success based on physician global assessments. Secondary endpoint included: difference in pruritus and Eczema Area and Severity Index (EASI) at day 29. Treatment was significant (P < 0.001) for HCB 0.1% LCr over vehicle. No serious nor significant adverse events were reported. Results are representative of a short duration treatment for a chronic disease. HCB 0.1% in LCr is more effective than its vehicle in pediatric populations down to 3 months of age without significant adverse events when used twice a day for up to 1 month.