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 © June 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
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.