Oracea (40mg slow release doxycycline) shows promise

Another paper readying the rosacea community for the release of Oracea. Collagenex have conducted studies so that they can market Oracea as a safe low-dose doxycyline treatment suitable for the long term treatment of rosacea.

Multicenter, double-blind, randomized, placebo-controlled, parallel-group trial results evaluating the effects of 40 mg doxycycline monohydrate controlled-release capsules in treatment of rosacea, James Del Rosso, DO, University of Nevada, Las Vegas, NV, United States; Joseph Bikowski, MD, Ohio State University, Columbus, OH, United States

A total of 537 patients were evaluated in two double-blind, randomized, placebocontrolled, parallel-group trials evaluating the efficacy and safety of 40 mg of doxycycline monohydrate controlled-release capsules administered once daily versus placebo capsules administered once daily over a duration of 16 weeks in adult patients with rosacea. The primary efficacy parameter was change in total inflammatory lesion count from baseline to end point. Secondary efficacy parameters were change in investigator global assessment and erythema assessment scale from baseline to end point as well as dichotomized investigator global assessment (percent of patients clear or near clear) at end point. In both trials, statistically significant greater reduction in inflammatory lesions (P < .001, P < .001) and change in investigator global assessment (P <.001, P < .004) were noted at all time points (weeks 3, 6, 12, and 16) in the active treatment group. In addition, a statistically significant difference in dichotomized investigator global assessment was observed in favor of the active treatment group (P < .036, P < .012). In one of the trials, the active treatment group demonstrated statistically significant greater reduction in erythema score as compared to placebo from baseline to end point (P < .017). Both the group treated with 40-mg doxycycline monohydrate controlled release capsules and the group treated with placebo capsules demonstrated favorable safety profiles. Specific study results are discussed in detail in the poster.

Author disclosure: Collagenex, Dermik, Doak, Galderma, Intendis, Medicis, Stiefel. 100% of poster production is sponsored by Collagenex.

Poster Discussion Session P164, American Academy of Dermatology, 64th Annual Meeting, March 3-7 2006, San Francisco.

Supplement to Journal of The American Academy of Dermatology, March 2006, Volume 54, Number 3.

• JAAD Poster Abstracts Online
• Clinical Trial Register: Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

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• Oracea approved by FDA for oral rosacea treatment

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