Low-Dose Oral Minocycline (DFD-29) and Achievement of Clear Skin Compared to Low-Dose Doxycycline and Placebo: A Pooled Analysis of Two Phase 3 Clinical Trials
Year: 2026
Type: article
Abstract: Background: Evidence suggests that complete clearance of rosacea, defined by a score of ‘0’ on the Investigator’s Global Assessment (IGA), is a clinically meaningful treatment outcome. In this post hoc pooled analysis of two randomized, double-blind phase 3 trials (MVOR-1 and MVOR-2), we evaluated the achievement of complete clearance in patients treated with DFD-29, doxycycline 40 mg modified-release, or placebo. Methods: MVOR-1 and MVOR-2 were randomized, double-blind, placebo-controlled, phase 3 clinical trials in adults aged ≥18 years with moderate-to-severe papulopustular rosacea conducted in the US and Germany. Participants were randomized in a 3:3:2 ratio to treatment with oral, low-dose minocycline hydrochloride capsules, 40 mg extended release (DFD-29), doxycycline 40 mg, or placebo once daily for 16 weeks. The primary endpoint of this post hoc analysis was the proportion of participants with completely clear skin, defined as IGA 0, at Week 16; secondary efficacy endpoints included IGA 0 rates at Weeks 2, 4, 8, and 12. Results: Of the 653 participants enrolled, 245 were randomized to DFD-29, 246 to doxycycline, and 162 to placebo. At baseline, 577 (88.4%) had moderate rosacea (IGA 3) and 76 (11.6%) had severe rosacea (IGA 4). By Week 16, significantly more participants receiving DFD-29 (29.7%) achieved clear skin (i.e., IGA 0) compared with participants receiving doxycycline (12.8%; P < 0.001) or placebo (6.4%; P < 0.001), indicating that the IGA 0 rate with DFD-29 was more than twice that with doxycycline and nearly 5 times that with placebo. Significant differences in rates of participants achieving IGA 0 were apparent as early as Week 4 and were maintained throughout the remainder of the trial. DFD-29 was generally well tolerated, with no notable differences in the frequency or severity of reported adverse events between treatment groups. Conclusion: A significantly greater proportion of patients with moderate-to-severe papulopustular rosacea treated with DFD-29 reported completely clear skin compared to those treated with doxycycline 40 mg or placebo. Routine reporting of clear skin (IGA 0) in addition to the conventional composite IGA 0/1 (clear/near clear) endpoint may provide a more informative evaluation of the benefit of rosacea interventions and better reflect contemporary treatment goals in rosacea. The study and the development of the abstract were funded by Journey Medical Corporation.
DOI: 10.25251/8727zb59
Authors: Mabel Maia, Seemal Desai
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7225739973