Update on the Management of Rosacea: A Status Report on the Current Role and New Horizons With Topical Azelaic Acid

Use of AzA 15% gel in combination with oral doxycycline expedites clinical improvement of PPR, especially in patients presenting with greater disease severity.^31-34 Once adequate control of a PPR flare was achieved within 1 to 3 months, AzA 15% gel applied twice daily proved to sustain satisfactory control of PPR in 75% of treated subjects over 6 months of follow-up.³²

The approved application frequency with AzA 15% gel is twice daily as this was the frequency in the pivotal studies submitted to obtain approval.^19,26,40 However, if patients with PPR end up applying AzA 15% gel once a day, there are published data to support comparable efficacy to twicedaily application.³⁷

In a 12-week study of PPR patients treated with doxy-MR 40 mg once daily in combination with either AzA gel 15% twice daily (n=106) or metronidazole 1% gel (metro 1%) once daily (n=101), efficacy parameters supported that both combination regimens were effective, with a trend toward earlier and greater therapeutic benefit with the AzA-based regimen than with the metronidazole-based regimen. Nominal differences were noted, but most were not statistically significant.³³

Subjects at baseline in both groups had a mean lesion count of approximately 20 papules and pustules, most patients were rated as moderate severity by investigator global assessment (IGA), and all had at least mild overall facial erythema.³³

After 2 weeks of treatment, a 25% reduction of papules and pustules was achieved by almost 85% of subjects in the AzA 15% gel group, with 61.3% and 20.8% of them achieving 50% and 75% reduction in papulopustular lesions, respectively. The percent lesion reductions observed in the metro 1% group were lower for each clearance category at each time point (Figure 3).

The percentage of patients achieving “treatment success” (IGA score of clear or minimal) was higher in the AzA 15% gel group compared with the metro 1% group at each time point. Statistical significance was reached at week 6 (P=.0097) (Figure 4).

The results of this study demonstrate comparable results in both groups, with support of an overall trend of quicker response and slightly greater efficacy in the AzA 15% gel treatment arm.³³

In 2008, the American Acne and Rosacea Society (AARS) published recommendations on the medical management of rosacea based on the most current research and clinical data available.¹⁸ These recommendations suggest the initial use of medical therapy that decreases the inflammation of rosacea (especially PPR) without the need for an antibiotic effect as there is no evidence that a bacterium is integral to the pathogenesis of rosacea, a concept that is well-supported based on currently available evidence.^{6,11,13,18-20} Most recently, the AARS has published current recommendations on the management of rosacea that address the most common presentations of the disease – central facial erythema without papulopustular lesions (commonly referred to as erythematotelangiectatic rosacea) and central facial erythema with papulopustular lesions (commonly referred to as papulopustular lesions).⁴⁷ These