A Randomized, Phase 2, Dose-Ranging Study in the Treatment of Moderate to Severe Inflammatory Facial Acne Vulgaris With Doxycycline Calcium

June 2013 | Volume 12 | Issue 6 | Original Article | 658 | Copyright © 2013

James J. Leyden MD,a Suzanne Bruce MD,b Chai Sue Lee MD,c,* Mark Ling MD PhD,d Pranav B. Sheth MD,e Daniel M. Stewart DO,f William P. Werschler MD,g Richard D. Gilbert PhD,h and Leon Kircik MDi

aDepartment of Dermatology, University of Pennsylvania, Philadelphia, and the Skin Study Center, KGL, Inc., Broomall, PA
bThe Center for Skin Research, Houston, TX
cDepartment of Dermatology, UC Davis, Sacramento, CA
dMedaPhase, Inc., Atlanta, GA
eDermatology Research Center of Cincinnati, Group Health Associates, Trihealth Inc., Cincinnati, OH
fMichigan Center for Skin Care Research, Clinton Township, MI
gUniversity of Washington, Seattle, WA and Premier Clinical Research, Spokane, WA
hTKL Research, Inc., Rochelle Park, NJ
iIndiana University School of Medicine, Indianapolis, IN, Mount Sinai Medical Center, New York, NY, and DermResearch, PLLC, Louisville, KY

Abstract

BACKGROUND: Doxycycline calcium (WC2055) is a drug substance with a possible role in the treatment of acne. The objective of this study was to evaluate the safety and efficacy of three doses of doxycycline calcium tablets compared with placebo in the treatment of moderate to severe inflammatory facial acne vulgaris.
METHODS: This was a randomized, double-blind, phase 2 dose-ranging study in subjects with moderate to severe inflammatory acne aged 12 years to 45 years. Subjects were randomized to receive doxycycline calcium tablets 0.6, 1.2, or 2.4 mg/kg/day or placebo, and instructed to take their tablets once daily for 12 weeks, in the evening at least 1 hour before or 2 hours after mealtime. The primary efficacy variables were the dichotomized Investigator's Global Assessment score (success or failure) at week 12 (success defined as ≥2 score decrease from baseline) and the absolute change from baseline to week 12 in inflammatory lesion count.
RESULTS: A dose-response effect was seen with doxycycline calcium formulation in subjects with moderate to severe inflammatory acne. The highest dose-group (corresponding to approximately 2.4 mg/kg/day) showed a statistically significant difference from placebo. The dose-response effect was confirmed by logistic regression analysis for both treatment success and incidence of gastrointestinal adverse events. A limitation of this study is that safety and efficacy were only studied on moderate to severe inflammatory acne. Also, the study was not prospectively powered to show efficacy differences.
CONCLUSION: Doxycycline calcium shows a dose-response effect in reducing inflammatory lesions in subjects with moderate to severe inflammatory acne.

J Drugs Dermatol. 2013;12(6):658-663.

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INTRODUCTION

Treatment guidelines for moderate to severe acne recommend early initiation of therapy with topical retinoids and oral antibiotics (with or without the use of benzoyl peroxide).1,2 Doxycycline and minocycline, both lipophilic tetracyclines, are commonly prescribed for the treatment of acne. Despite widespread use, however, no dose-response data exist for doxycycline in subjects with acne.

A dose-ranging study with minocycline in subjects with acne reported equivalent efficacy between the three oral doses studied (1, 2, or 3 mg/kg).3 However, it should be noted that although minocycline 1 mg/kg was significantly better tolerated, a dose-response for efficacy was not seen; the robustness of these data are limited by the lack of a logistic regression analysis.4 The present study is the first dose-response study of doxycycline calcium (WC2055; Warner Chilcott US LLC, Rockaway, NJ, USA), a substance formed in situ from doxycycline hyclate and calcium chloride. The safety and efficacy of three doses of doxycycline calcium tablets compared with placebo were evaluated in the treatment of subjects with moderate to severe, inflammatory, facial acne vulgaris.

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