MVOR-2 (minocycline vs. placebo)
Trial question
What is the effect of low-dose minocycline hydrochloride, DFD-29, in participants with papulopustular rosacea?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
80.0% female
20.0% male
N = 205
205 patients (165 female, 40 male).
Inclusion criteria: adults with moderate-to-severe papulopustular rosacea.
Key exclusion criteria: ≥ 2 nodules or cysts at baseline; use of any topical or systemic rosacea treatment, systemic corticosteroids, immunosuppressive agents, or immunomodulators in the previous 30 days; use of systemic retinoids in the previous 6 months; use of anti-inflammatory agents in the 2 weeks preceding the baseline visit; pregnancy.
Interventions
N=123 low-dose minocycline (minocycline hydrochloride [DFD-29] capsules 40 mg once daily for 16 weeks).
N=82 placebo (matching placebo once daily for 16 weeks).
Primary outcome
Investigator's Global Assessment success rate
60.1%
26.8%
60.1 %
45.1 %
30.1 %
15.0 %
0.0 %
Low-dose
minocycline
Placebo
Significant
increase ▲
NNT = 3
Significant increase in Investigator's Global Assessment success rate (60.1% vs. 26.8%; AD 34.1%, 95% CI 21.3 to 46.8).
Secondary outcomes
Significantly greater reduction in least-squares mean total inflammatory lesion counts (18 points vs. 11.1 points; AD 6.8 points, 95% CI 4.8 to 8.9).
Significantly greater reduction in least-squares mean total inflammatory lesion counts at week 16 (75.4% vs. 46.3%; ARD 29.1, 95% CI 20.14 to 38.04).
Significant increase in participants with ≥ 2-grade reduction in Clinician's Erythema Assessment at week 16 (24.5% vs. 12%; AD 13.9%, 95% CI 3.71 to 23.99).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In adults with moderate-to-severe papulopustular rosacea, low-dose minocycline was superior to placebo with respect to Investigator's Global Assessment success rate.
Reference
Neal Bhatia, James Del Rosso, Linda Stein Gold et al. 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 Mar 5:e246542. Online ahead of print.
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