A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Efficacy and Safety of Clindamycin 1.2% and Tretinoin 0.025% Combination Gel for the Treatment of Acne Rosacea Over 12 Weeks
March 2012 | Volume 11 | Issue 3 | Original Article | 333 | Copyright © March 2012
Anne Lynn S. Chang MD,a Maria Alora-Palli, MD,b Xinaida T. Lima MD MPH, b Tiffany C. Chang,a Carol Cheng BA,b Connie M. Chung BA,b Omar Amir MS,a Alexa B. Kimball MD MPHb
aStanford University School of Medicine, Redwood City, CA bMassachusetts General Hospital, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS), Boston, MA
Abstract
Background: Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features.
Objective: To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage.
Methods: Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage.
Results: There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug.
Conclusions: A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings. Clinical Trials: NCT00823901.
J Drugs Dermatol. 2012;11(3):333-339.
INTRODUCTION
Acne rosacea is a common chronic disease affecting up to 10% of fair-skinned individuals.1 It is characterized by inflammation and vascular abnormalities of primarily the facial skin and ocular surface. It can encompass various combinations of cutaneous signs including erythema, telangiectasia, papules, pustules, edema, ocular lesions and rhinophyma. The exact etiology of cutaneous rosacea is unknown, but is thought to be characterised by persistent vasodilatation, increased vascular permeability and vascular hyper-reactivity of the microcirculation of the central part of the face. Perifollicular dermal inflammation, elastin and collagen degeneration, and vascular dilatation are important findings in its histopathology.2
The National Rosacea Society Expert Committee proposed a classification and staging system. This system defines four subtypes: erythemato-telangiectatic, papulopustular, phymatous, and ocular.3 Although rosacea is not clearly of infectious origin, oral and topical antibiotics (such as tetracyclines, macrolides, metronidazole) are effective in treating the papulopustular subtype of rosacea. More recently, submicrobial doses of doxycycline have been shown to improve rosacea through its putative anti-inflammatory properties.4
In recalcitrant cases where antibiotics have failed or are only partially successful, oral or topical tretinoin therapy may be
