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Dermatol Ther. 2021 Oct 29:e15180. doi: 10.1111/dth.15180. Online ahead of print.

ABSTRACT

BACKGROUND: An important goal of effective rosacea treatment is to maximize the duration of remission.

METHODS: This was a 2-part study. Part 1 was a multicenter, open-label, 12-week study in which adults with moderate or severe inflammatory lesions (papules and pustules) of rosacea received subantibiotic dose oral doxycycline 40mg modified release (SDD40 ) and topical metronidazole gel 1%. Part 2 was a multicenter, randomized, double-blind, placebo-controlled, 40-week study in which successfully treated subjects received once-daily SDD40 or placebo capsules. The primary objective was to assess relapse and efficacy during long-term use of SDD40 versus placebo. Relapse was defined as a return to baseline Investigator Global Assessment (IGA) or lesion count, or any other necessary change in treatment.

RESULTS: Part 1 enrolled 235 subjects. Sixty-five subjects in the SDD40 treatment group and 65 subjects in the placebo group met the definition of treatment success at week 12, and were included in the part 2 analysis. At the end of part 2, half as many subjects in the SDD40 group had relapsed compared to the placebo group (13.8% [n = 9] vs. 27.7% [n = 18], P < .05). Significant differences in the median change in inflammatory lesion counts were also observed (P < .05). Adverse events (AEs) were generally mild-moderate in severity, and most were not treatment-related. Stinging/burning responded with more improvement in subjects treated with SDD40 .

CONCLUSION: After 52 weeks of once-daily treatment, subantibiotic dose doxycycline significantly reduced the relapse rate and inflammatory lesion counts in subjects with moderate-to-severe inflammatory rosacea. This article is protected by copyright. All rights reserved.

PMID:34713539 | DOI:10.1111/dth.15180

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