11.08
Journal of Drugs in Dermatology, March, 2008 by Robert Matheson, Steven Kempers, Debra Breneman, Zoe Draelos, Candice E. Johnson, Robert Loss, Daniel J. Hogan, Robert Schoenfeld, Scott Checketts, Leon Kircik, David Fivenson, Adelaide A. Hebert, Judith Williams, Regina Hamlin, Daniel Groisser, Dan Piacquadio
Introduction
Topical corticosteroids have become the cornerstone of treatment for a variety of inflammatory dermatoses, including atopic dermatitis (AD), eczema, and psoriasis. A wide selection of topical corticosteroid products is available and psoriasis oil the potency of these formulas depends on several factors, including the inherent activity of the steroid molecule, concentration of the active ingredient, duration of treatment, and nature of the vehicle.
Hydrocortisone butyrate (HCB) is a synthetic, nonfluorinated, glucocorticoid developed in the early 1970s. Hydrocortisone butyrate in other semi-solid dosage forms has been found to be a midpotency topical corticosteroid. Hydrocortisone butyrate 0.1% lotion may provide physicians with a formulation that is easier to apply to extensive areas of disease than creams and ointments.
Methods
Objectives
The primary objective of this study was to evaluate efficacy of a twice-daily application of HCB 0.1% lotion as compared to the vehicle in infants and children aged 3 months to less than 18 years diagnosed with mild to moderate AD. The secondary objective was to evaluate the safety of HCB 0.1% lotion as compared to the vehicle by evaluating reported and observed adverse events.
Design
This multicenter, randomized, parallel group, vehicle controlled study was designed to demonstrate statistical significance of the HCB 0.1% lotion in comparison to its vehicle. The vehicle used in this study was a matched vehicle containing all of the same components of the drug product exclusive of the active ingredient, HCB.
Subjects were assigned to either HCB 0.1% lotion or to the vehicle treatment group in a 1:1 ratio according to a computer-generated randomization scheme. Treatments were randomly assigned to consecutive subject numbers using permuted blocks with a random block size of 4. Upon enrollment into the study, the investigator dispensed subject kits to those determined by the inclusion/exclusion criteria. Each kit was labeled with the subject number and contained 6 double-blind labeled bottles of study treatment. The investigators, subjects, and study sponsor were blinded to the treatment assignments throughout the conduct of the study.
The treatment duration was 4 weeks. Subjects were scheduled for a screening and 5 visits: baseline (day 1), 3 interim visits (days 8, 15, and 22), and a final visit (day 29). Dosing was twice-daily of the HCB 0.1% or vehicle lotion without occlusive dressing to the areas affected by AD. A review of adverse events and concomitant medications was performed at each visit. If a subject achieved total clearing, Physician Global Assessment (PGA)=0, as determined by the investigator at the day 22 visit, treatment was discontinued at that time
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