A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)

Summary

This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.

Timeline

Start

2022-03-29

Primary completion

2023-06-30

Completion

2023-06-30

Publications

• Bhatia N, Del Rosso J, Stein Gold L, Lain E, Draelos ZD, Sidgiddi S; MVOR-1 and MVOR-2 Study Investigators. Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2025 May 1;161(5):499-507. doi: 10.1001/jamadermatol.2024.6542.

Drugs

Indications