Efficacy of Oral Dfd-29, a Low-Dose Minocycline Formulation, by Baseline Rosacea Severity in Two Phase 3 Trials
Recommended Citation
Sidgiddi S, Stein Gold L, Gallo R, Dhawan S, Bayar S, Sidgiddi S. Efficacy of Oral Dfd-29, a Low-Dose Minocycline Formulation, by Baseline Rosacea Severity in Two Phase 3 Trials. J Am Acad Dermatol 2026; 95(1):AB192.
Document Type
Conference Proceeding
Publication Date
7-1-2026
Publication Title
J Am Acad Dermatol
Keywords
Dermatology
Abstract
Background: We compared the efficacy of a modified low-dose formulation of minocycline hydrochloride 40 mg (DFD-29), doxycycline 40 mg, and placebo in participants with moderate versus severe rosacea. Methods: In two double-blind, placebo-controlled, phase 3 clinical trials (MVOR-1 and MVOR-2), adults aged ≥18 years with moderate-to-severe rosacea were randomized (ratio, 3:3:2) to oral DFD-29, doxycycline 40 mg, or placebo QD for 16 weeks. Coprimary efficacy endpoints were (1) proportions of participants demonstrating Investigator’s Global Assessment (IGA) success with DFD-29 vs placebo and (2) reductions in total inflammatory lesion counts (ILC) with DFD-29 vs placebo. Comparisons between DFD-29 and doxycycline were secondary endpoints. Results: Of the 653 participants randomized, 577 (88.4%) had moderate rosacea and 76 (11.6%) had severe rosacea. Among participants with moderate rosacea on DFD-29, doxycycline, or placebo, IGA success was achieved in 64.6%, 47.8%, and 37.1% in MVOR-1 and 64.1%, 33.0%, and 26.6% in MVOR-2, respectively. In severe rosacea, 66.7%, 62.5%, and 0% in MVOR-1 and 41.7%, 15.4%, and 25.0%, respectively, in MVOR-2, achieved IGA success. Mean ILC changes from baseline (mean [SD]) with DFD-29, doxycycline, and placebo were -19.6[10.2], -14.6[8.3], -12.2[8.7] in moderate rosacea in MVOR-1 and -16.7[7.9], -14.0[9.2], and -11.2[9.9] in MVOR-2, respectively. In severe rosacea, mean ILC changes were -29.2[12.4], -17.8[15.9], and -11.2[12.5] in MVOR-1 and -23.8[8.2], -19.8[16.4], and -15.5[8.7] in MVOR-2, respectively. Conclusion: There were no clinically meaningful differences in DFD-29 efficacy by baseline rosacea severity and the efficacy of DFD-29 was greater than that of doxycycline and placebo in all subgroups.
Volume
95
Issue
1
First Page
AB192
