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Journal of the American Academy of Dermatology
Volume 74, n° 6
pages 1086-1092 (juin 2016)
Doi : 10.1016/j.jaad.2016.01.023
accepted : 20 January 2016
Original Articles

Improved clinical outcome and biomarkers in adults with papulopustular rosacea treated with doxycycline modified-release capsules in a randomized trial
 

Anna Di Nardo, MD, PhD a, , Anna D. Holmes, PhD b, Yumiko Muto, BS a, Eugene Y. Huang, MD, PhD c, d, Norman Preston, PhD b, Warren J. Winkelman, MD, PhD b, Richard L. Gallo, MD, PhD a
a Department of Dermatology, University of California–San Diego, School of Medicine, La Jolla, California 
b Galderma Laboratories LP, Fort Worth, Texas 
c Therapeutics Clinical Research, San Diego, California 
d Department of Veterans Affairs San Diego Healthcare System, San Diego, California 

Reprint requests: Anna Di Nardo, MD, PhD, Department of Dermatology, University of California–San Diego, School of Medicine, 9500 Gilman Dr, PO Box 0869, La Jolla, CA 92093.Department of DermatologyUniversity of California–San DiegoSchool of Medicine9500 Gilman Dr, PO Box 0869La JollaCA92093
Abstract
Background

Patients with rosacea have increased amounts of cathelicidin and protease activity but their usefulness as disease biomarkers is unclear.

Objective

We sought to evaluate the effect of doxycycline treatment on cathelicidin expression, protease activity, and clinical response in rosacea.

Methods

In all, 170 adults with papulopustular rosacea were treated for 12 weeks with doxycycline 40-mg modified-release capsules or placebo in a multicenter, randomized, double-blind, placebo-controlled study. Clinical response was compared with cathelicidin and protease activity in stratum corneum samples obtained by tape strip and in skin biopsy specimens obtained from a random subset of patients.

Results

Treatment with doxycycline significantly reduced inflammatory lesions and improved investigator global assessment scores compared with placebo. Cathelicidin expression and protein levels decreased over the course of 12 weeks in patients treated with doxycycline. Low levels of protease activity and cathelicidin expression at 12 weeks correlated with treatment success. Low protease activity at baseline was a predictor of clinical response in the doxycycline treatment group.

Limitations

Healthy control subjects were not studied.

Conclusions

Improved clinical outcome correlated with reduced cathelicidin and protease activity, supporting both the mechanism of doxycycline and the potential of these molecules as biomarkers for rosacea.

The full text of this article is available in PDF format.

Key words : biomarker, cathelicidin, doxycycline, kallikrein, matrix metalloproteinase, papulopustular, rosacea, serine protease

Abbreviations used : AE, BCA, CAMP, cDNA, GAPDH, hCAP18, IGA, KLK, MMP, mRNA, PEG, pTP



 Funding for clinical research study provided by Galderma Laboratories LP.
 Disclosure: Dr Holmes, Preston, and Winkelman were employees of Galderma Laboratories LP when this work was conducted. Drs Di Nardo, Huang, and Gallo, and Ms Muto have no conflicts of interest to declare.
 Investigator global assessment success rates for the intent-to-treat population were presented in poster form at the Society for Investigative Dermatology meeting on May 8-11, 2013 in Edinburgh, Scotland, the American Academy of Dermatology meeting on March 21-25, 2014 in Denver, CO, and the Winter Clinical meeting on January 17-22, 2014 in Waimea, HI. Investigator global assessment success rates for the subpopulation recently given a diagnosis of rosacea were presented in poster form at the Winter Clinical meeting on January 17-22, 2014 in Waimea, HI.



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