Topical use of azelaic acid in the treatment of rosacea - results of a multicenter study
Topical application of 15% azelaic acid gel in combination with oral doxycycline and azelaic acid monotherapy as supportive therapy is effective and safe in the treatment of moderate to severe papulopustular forms of rosacea.
The purpose of a multicenter study at the University of Pennsylvania State College of Medicine (Hershey, USA) was to determine the efficacy and safety of a combination of doxycycline indoors and topical use azelaic acid in the form of a 15% gel in the treatment of moderate to severe papulosis-pustular forms of rosacea (rosacea) followed by a 15% azelaic acid gel as a supportive treatment.
In the first open, non-randomized phase of this study, patients (n = 172) received azelaic acid 15% gel locally 2 times a day and doxycycline 100 mg orally twice a day for less than 12 weeks. In the second double-blind phase of the study, patients who had initially received combination therapy for at least 4 weeks during the 1st phase of the study and who achieved a reduction in the number of inflammatory foci of more than 75% (n = 136) were randomized to 15% azlainic acid gel or placebo for an additional 24 weeks.
The evaluation of the efficacy of the treatment was carried out every 4 weeks during the two phases of the study and included a change in the number of inflammatory foci, an overall evaluation of the severity of rosacea carried out by the research doctor and a separate assessment of the severity of erythema and telangiectasia.
During the last visit in each of the two phases, the researcher and each study participant evaluated the overall improvement with an evaluation of the patient on the scale of cosmetic acceptability of the treatment results and an evaluation of the researcher on the global rosacea severity scale as `` clinical success of treatment '' or `` treatment failure ''.
During the second phase of the study, the relapse rate was also evaluated, which was determined to be either a 50% worsening of the inflammatory foci compared to the state reached in the first phase of the study. , an increase in erythema, either by evaluating the ineffectiveness of maintenance treatment according to the researcher and / or the patient. The safety assessment was carried out in both phases of the study and included an analysis of adverse events and an assessment of the skin tolerance of the patient's treatment.
At week 12 of the open phase of the study, 81.4% of patients showed a decrease in the number of inflammatory elements by 75% or more, and in 64% of study participants, marked clinical success of treatment has been obtained. In the second phase of the study, topical administration of 15% azelaic acid gel provided marked maintenance of treatment effect compared to placebo - thus, remission was observed in 75 % of patients within 6 months of the second phase. In addition, the use of azelaic acid gel showed statistically significantly less deterioration in terms of absolute number of inflammatory elements compared to placebo after 8, 16, 20 and 24 weeks of maintenance treatment. During the study, there were no serious adverse events due to treatment and 98.5% of patients were satisfied with the local tolerance of azelaic acid gel and placebo.