Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for Rosacea: Summary of a Placebo-Controlled, Double-Blind Trial

December 2012 | Volume 11 | Issue 12 | Original Article | 1410 | Copyright © December 2012


Scott A. Freeman MS PA-C,a Summer D. Moon BS,b and James M. Spencer MD MSa,c

aSpencer Dermatology, St. Petersburg, FL bLake Erie College of Osteopathic Medicine, Bradenton, FL cDepartment of Dermatology, Mount Sinai School of Medicine, New York, NY

Abstract
Rosacea is a common, chronic, and poorly understood dermatological condition characterized by an inflammatory component composed of papules and pustules and a vascular component composed of flushing and erythema. Current treatment options include topical, systemic, and light-based methods, each of which focuses on either the inflammatory or the vascular component. Retinoids are not routinely indicated as treatment because of the common conception that they would be too inflammatory for the sensitive rosacea patient. However, photodamage may play a role in rosacea and tretinoin is well-known to repair photodamage. Thirty rosacea subjects were enrolled to assess their response to the use of clindamycin phosphate 1.2% and tretinoin 0.025% gel (ZIANA; Medicis Pharmaceutical Corporation, Scottsdale, AZ) for a period of 12 weeks. The results showed a dramatic decrease in pustules and papules without any significant inflammation or overall intolerance. No improvement in facial redness was achieved. Based on our results, more investigation of topical retinoids for rosacea treatment is prudent.

J Drugs Dermatol. 2012;11(12):1410-1414.

INTRODUCTION

Rosacea is a common, chronic dermatologic condition that most commonly affects sun-sensitive, pale-skinned individuals of Northern or Eastern European descent and those of Celtic heritage.1-3There is no clearly identified cause or cure for rosacea; therefore, this condition is managed rather than cured.4-6Triggers such as weather, ultraviolet radiation, medications, emotional stress, spicy foods, alcohol consumption, menopause, and strong emotions are known to induce the skin changes. Commonly, patients present with central facial vasodilation causing flushing and ultimately persistent telangiectasias, whereas others have acne, including papules and pustules. These findings are the 2 main components associated with the diagnosis of rosacea. The papular/pustular, or inflammatory, component responds to topical antibiotics, and light-based treatments are often effective for the telangiectasias. There is currently no topical treatment that has the ability to completely clear the redness associated with rosacea.
Current rosacea treatment options include topical antibiotics (metronidazole and sulfur-containing compounds), topical azelaic acid, oral antibiotics (tetracycline class), and light-based treatments, specifically intense pulsed light and pulsed dye laser.
Some therapies seem counterintuitive yet have had successful anecdotal reports, such as the use of a retinoid. Clinically, we understand that most rosacea patients have naturally sensitive skin that could worsen with the application of an irritating retinoid. However, it has been suggested that photodamage may play a role in rosacea. Retinoids have been shown histologically to improve and repair photodamage; theoretically, they may be helpful.7
Clindamycin phosphate 1.2% and tretinoin 0.025% gel (ZIANA; Medicis Pharmaceutical Corporation, Scottsdale, AZ) is approved by the US Food and Drug Administration for acne vulgaris and may have a role in rosacea therapy. Due to its retinoid component, the investigators hope to demonstrate this treatment's efficacy and lack of irritancy in rosacea patients. This trial looks at tolerability and therapeutic efficacy of clindamycin phosphate 1.2% and tretinoin 0.025% gel in rosacea subjects.

METHODS

Thirty subjects with a clinical presentation of rosacea were recruited. Subjects included were between the ages of 18 and 65 years, in good health other than inflammatory rosacea, had Fitzpatrick skin types I to III, a tendency to flush or blush easily, and had persistent redness in the central portion of the face. Subjects had to be willing and able to avoid excessive sun exposure and commit to all follow-up visits for the duration of the study. Subjects also had to be willing to allow the study sponsor to use and distribute the photos/images for education and information purposes, general and or professional advertising, publicity and promotional purposes, including distribution to the media and in publication of the scientific work. After explaining the nature of the study, subjects read, signed, and received a copy of the informed consent.