Efficacy, Tolerance, and Safety of a Novel Botanical Anti‐Inflammatory Moisturizer in Rosacea: Results From a Double‐Blinded, Randomized Controlled Trial

BACKGROUND: Rosacea is characterized by facial erythema that can be resistant to improvement. AIMS: This research evaluated the efficacy and tolerability of a topical anti-inflammatory moisturizer containing oat and aloe as compared to 0.75% metronidazole cream over 12 weeks. METHODS: This double-blinded, randomized, controlled trial enrolled 60 adults with mild-to-severe rosacea, randomized to either the study anti-inflammatory moisturizer or 0.75% metronidazole cream daily for 12 weeks. Participants were evaluated at baseline and Weeks 4, 8, and 12. Efficacy was measured by investigator global assessment (IGA) of erythema and inflammatory lesion counts. Tolerability was assessed by the investigator and subjects. RESULTS: Both study products demonstrated similar IGA scores at Week 4. By Week 8, the study oat and aloe anti-inflammatory moisturizer demonstrated significantly greater reduction in both erythema IGA (50% vs. 22%, p = 0.001) and lesion counts (74% vs. 6%, p = 0.015). At the conclusion of the 12-week study, the anti-inflammatory moisturizer produced a reduction in IGA erythema of 54% vs. 23% (p < 0.001) and a reduction in inflammatory lesion counts of 74% vs. 17% (p = 0.044). No tolerability issues were noted. CONCLUSIONS: The oat and aloe anti-inflammatory moisturizer was superior and outperformed 0.75% metronidazole cream in both erythema and lesion reduction in rosacea subjects after 8 and 12 weeks of treatment.