Prolonged Remission in Rosacea: A Breakthrough With Subantibiotic Dose of Oral Doxycycline

Achieving and sustaining remission in rosacea patients presents a significant challenge, given the cyclical nature of exacerbations and remissions.

“Treatment combining topical metronidazole gel 1% and subantibiotic dose doxycycline (SDD) [dosing to avoid antibiotic resistance, previously referred to as subantimicrobial], administered as once-daily 40 mg modified-release capsules [30 mg of immediate-release and 10 mg delayed-release via beads], has been shown to produce a more rapid and greater reduction of papules and pustules compared with topical metronidazole monotherapy,” explained James Del Rosso, DO; Sam Brantman, PharmD; and Hilary Baldwin, MD, in their recent research.¹

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However, the long-term efficacy of SDD₄₀ in sustaining remission remained unexplored. Investigators launched a study to evaluate that and presented data in a poster session at Maui Derm NP+PA Fall 2023 in Asheville, North Carolina from September 27-30.¹

Study Design

This comprehensive 2-part study aimed to evaluate the extended remission capabilities of SDD₄₀ monotherapy. Part 1 involved a multicenter, 12-week open-label study wherein adults with moderate or severe inflammatory lesions of rosacea received SDD₄₀ in combination with topical metronidazole gel 1%. Part 2 was a 40-week randomized, double-blind, placebo-controlled trial. Successfully treated subjects were randomly assigned to receive once-daily SDD₄₀ or placebo capsules. The primary objective was to assess relapse rates and efficacy during long-term SDD₄₀ use versus placebo.

Study Results

Part 1 enrolled 235 subjects, of which 65 in both the SDD₄₀ treatment group and placebo group met the criteria for treatment success at week 12 and proceeded to part 2. At the end of part 2, a remarkable outcome emerged: only 13.8% of subjects treated with SDD₄₀ experienced relapse, compared to 27.7% in the placebo group (P < .05). Furthermore, there were significant differences in the median change in inflammatory lesion counts (P < .05). Adverse events were generally mild or moderate, with most being unrelated to the treatment. Notably, subjects treated with SDD₄₀ reported greater improvement in stinging and burning sensations.

Conclusions and Take Home Pearls

This study reveals that after an initial 12-week treatment regimen, continued use of once-daily SDD₄₀ significantly reduces the relapse rate and inflammatory lesion counts in subjects with moderate-to-severe rosacea. These findings herald a major advancement in rosacea management, offering new hope for sustained remission and improved quality of life for patients.

Reference

1. Del Rosso J, Brantman S, Baldwin H. Maximizing remission in rosacea with subantibiotic dose oral doxycycline 40 mg modified-release capsules once daily. Poster presented at: Maui Derm NP+PA Fall 2023; September 27-30, 2023; Asheville, NC.