Long-term inflammatory rosacea management with subantibiotic dose oral doxycycline 40 mg modified-release capsules once daily.

Abstract

An important goal of effective rosacea treatment is to maximize the duration of remission. This was a two‐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 40 mg 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. 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 < 0.05). Significant differences in the median change in inflammatory lesion counts were also observed (p < 0.05). 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. 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.