Hydrocortisone Butyrate 0.1% Lotion in the Treatment of Atopic Dermatitis in Pediatric Subjects

March 2008 | Volume 7 | Issue 3 | Original Article | 266 | Copyright © March 2008

Robert Matheson MD, Steven Kempers MD, Debra Breneman MD, Zoe Draelos MD, Candice E. Johnson MD PhD,Robert Loss MD, Daniel J. Hogan MD, Robert Schoenfeld MD, Scott Checketts MD, Leon Kircik MD,David Fivenson MD, Adelaide A. Hebert MD, Judith Williams MD, Regina Hamlin MD, Daniel Groisser MD,Dan Piacquadio MD

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.