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...evaluable efficacy population of this 12-week double-blind, parallel-group study included 72 patients and the population that was used to report safety results included 92 patients. Baseline characteristics were comparable between the once-daily and twice-daily study groups. Evaluations were performed at baseline and at weeks 4, 8, and 12.
Results: No significant difference was found between the once-daily and twice-daily groups at the end of study therapy in mean investigator global assessment (IGA) scores, treatment success, or treatment response. The mean number of inflammatory lesions, the intensity of erythema intensity, and the intensity of telangiectasia at treatment end were likewise not significantly different (P>.205 for all). More than 90% of subjects in each group rated cosmetic acceptability of this AzA gel as satisfactory or better.
Conclusion: Based on these findings and those of prior studies, once-daily AzA 15% gel can therefore be utilized as a safe, effective, and economical dosing option for the treatment of mild-to-moderate papulopustular rosacea. Once-daily dosing of AzA 15% gel was well accepted by patients and can offer considerable dosing flexibility and convenience for the patient as well as for the dermatologist.
Introduction
Rosacea is a common, chronic, relapsing cutameous disorder that is reported to affect more than 1 in 20 individuals in the US. (1) It is characterized by a variety of central facial signs and symptoms and can be classified into 4 main subtypes: erythematotelangiectatic, papulopustular, phymatous, and ocular. (2) In most patients, combinations of signs and symptoms from 1 or more subtypes appear in a pattern of exacerbation and remission. (2) Recently, it has been suggested that the inflammatory changes in rosacea may be due to an increased activity of antimicrobial peptides in facial skin. (3)
Current treatment is directed at reduction of symptoms and includes topical agents and systemic antibiotics. (4) One of the most effective topical treatments for mild to moderate papulopustular rosacea is azelaic acid (AzA), a naturally occurring dicarboxylic acid that has proven anti-inflammatory effects, as well as antikeratinizing and antimicrobial action, although its mechanism of action in rosacea is not well understood. (5-8) Azelaic acid 15% aqueous gel was approved for mild to moderate papulopustular rosacea in the US in 2002 and in the European Union in 2003-the first new drug class to be approved for rosacea in more than a decade. (6) Among the advantages offered by the micronized solubilized 15% gel formula over the previously used 20% cream formulation (indicated for the treatment of mild to moderate acne vulgaris) are improved drug release and better absorption. (6)
Although the labeled dosage of AzA 15% gel is twice daily in the US, (5) a once-daily regimen is sometimes used in clinical practice. (9) A single daily dose appears desirable by offering additional dosing convenience without loss of efficacy. Therapeutic failure may reflect problems with adherence to a prescribed therapy regimen and is not necessarily overcome by increasing the number of daily doses. A number of studies involving different medication classes have indicated that patient compliance was apparently inversely related to the frequency of dosing. (10-14) Conversely, however, it must also be taken into account that reducing the frequency of medication may yield poor therapeutic results if drug concentrations fall below the therapeutic threshold.
Azelaic acid 15% gel has consistently been proven safe and effective in patients with papulopustular rosacea, (15), (16) but a once-daily AzA gel regimen, a clearly useful alternative, has not been carefully studied to date under controlled conditions. To address this issue, an exploratory multicenter, double-blind, parallel-group study of AzA 15% gel was conducted in patients with papulopustular rosacea to compare the safety and efficacy of a once-daily regimen with that of the conventional twice-daily treatment....
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