A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.

Phase 3 Completed 323 enrolled Journey Medical Corporation Dr. Reddy's Laboratories Limited · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2022-03-14
Primary completion: 2023-06-30
Completion: 2023-06-30

Outcome

Met primary endpoint

paper DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo (MVOR-1: treatment difference [TD], 32.9%; 95% CI, 19.6-46.2; P < .001 PMID 40042869 ↗

paper DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo (MVOR-1: TD, -9.2; 95% CI, -11.5 to -6.9; P < .001 PMID 40042869 ↗

release “Both clinical trials achieved the co-primary and all secondary endpoints” journeymedicalcorp.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Comparator	Doxycycline	Small molecule	40 mg	—
Subject	Minocycline	Small molecule	40 mg	—