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J Drugs Dermatol ; 7(3): 266-71, 2008 Mar.
Article in English | MEDLINE | ID: mdl-18380208

ABSTRACT

BACKGROUND: Hydrocortisone butyrate (HCB) is currently marketed as a cream, ointment, and solution. A new lotion formulation of hydrocortisone butyrate 0.1% (Locoid lotion) has been developed and evaluated. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of HCB 0.1% lotion compared to the vehicle in subjects aged 3 months to less than 18 years with mild to moderate atopic dermatitis (AD). METHODS: In this multicenter double-blind study, 284 subjects with mild to moderate AD were randomized 1:1 to receive HCB 0.1% lotion or the vehicle for a duration of 4 weeks. "Treatment success" was defined as those subjects with a final Physician Global Assessment (PGA) score of 0 or 1 that had at least a 2-point reduction in the PGA score from baseline to day 29. Safety was assessed by monitoring adverse events. RESULTS: Analyses of the final PGA score showed a significant treatment effect (P <.001) in favor of the HCB 0.1% lotion group. The safety profile of the HCB 0.1% lotion was also favorable. LIMITATIONS: The study did not assess the durability of the treatment effects (ie, safety and efficacy) after completion of the 4-week treatment period nor the potential need for longer term therapy given the chronic nature of AD. CONCLUSION: Results demonstrate the safety and efficacy of HCB 0.1% lotion in the treatment of mild to moderate AD in children 3 months to 18 years of age.


Subject(s)
Dermatitis, Atopic/drug therapy , Hydrocortisone/analogs & derivatives , Immunosuppressive Agents/therapeutic use , Administration, Cutaneous , Adolescent , Child , Child, Preschool , Dermatitis, Atopic/complications , Double-Blind Method , Female , Humans , Hydrocortisone/adverse effects , Hydrocortisone/therapeutic use , Immunosuppressive Agents/adverse effects , Infant , Male , Pruritus/drug therapy , Pruritus/etiology , Severity of Illness Index , Treatment Outcome
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