Patient-Reported Outcomes of Azelaic Acid Foam 15% for Patients With Papulopustular Rosacea: Secondary Efficacy Results From a Randomized, Controlled, Double-blind, Phase 3 Trial
Patient-reported treatment outcomes are important for evaluating the impact of drug therapies on patient experience. A randomized, double-blind, vehicle-controlled, parallel-group, multicenter, phase 3 study was conducted in 961 participants to assess patient perception of efficacy, utility, and effect on quality of life (QOL) of an azelaic acid (AzA) 15% foam formulation for the treatment of papulopustular rosacea (PPR). Secondary end points included patient-reported global assessment of treatment response, global assessment of tolerability, and opinion on cosmetic acceptability and practicability of product use. Quality of life assessments included the Dermatology Quality of Life Index (DLQI) and Rosacea Quality of Life Index (RosaQOL). Self-reported global assessment of treatment response favored AzA foam over vehicle foam (P<.001), with 57.2% of the AzA foam group reporting excellent or good improvement versus 44.7% in the vehicle foam group. Tolerability was rated excellent or good in 67.8% of the AzA foam group versus 78.2% of the vehicle foam group. Mean overall DLQI scores at end of treatment (EoT) were improved (P=.018) in favor of the AzA foam group compared with the vehicle foam group. Both treatment groups showed improvements in RosaQOL. Treatment with AzA foam was associated with improved QOL and meaningful reductions in the patient-perceived burden of PPR, which correlates with earlier reported primary end points of this study and supports the inclusion of patient perspectives in studies evaluating the effects of topical dermatologic treatments.
Practice Points
- Patient perceptions of treatment are an important consideration in developing topical therapeutic strategies for papulopustular rosacea.
- A novel hydrophilic foam formulation of azelaic acid (AzA) provided substantial benefits in patient-reported measures of treatment response and quality of life.
- Patients reported high levels of satisfaction with the usability, tolerability, and practicability of AzA foam.
- The positive treatment experience described by patients parallels investigator-reported measures of clinical efficacy reported elsewhere.
Conclusion
These results indicate that use of AzA foam as well as its novel vehicle results in high patient satisfaction and improved QOL. Although additional research is necessary to further delineate the relationship between PROs and other measures of clinical efficacy, our data demonstrate a positive treatment experience as perceived by patients that parallels the clinical efficacy of AzA foam for the treatment of PPR.13,14
Acknowledgment
Editorial support through inVentiv Medical Communications (New York, New York) was provided by Bayer Pharmaceuticals.
