Efficacy, safety, and tolerability of oral DFD-29, a low-dose formulation of minocycline, in rosacea: Two phase 3 randomized clinical trials

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Dr. Manjunath J V
M.B.B.S. M.D. (SKIN & V.D.)
Naik Skin Clinic

In the treatment of moderate-to-severe papulopustular rosacea (PPR), the low-dose modified formulation of minocycline hydrochloride, DFD-29, appears to have superior efficacy compared with both doxycycline and placebo, according to data from the phase III MVOR-1 and MVOR-2 studies.

MVOR-1 included 323 participants (mean age 47.2 years, 76.5% women), while MVOR-2 involved 330 individuals (mean age 51.6 years, 75.5% women). The participants were randomly assigned to receive treatment with oral DFD-29 40 mg, doxycycline 40 mg, or placebo once daily for 16 weeks.

The coprimary efficacy outcomes were (1) Investigator’s Global Assessment (IGA) treatment success with DFD-29 vs. placebo and (2) total inflammatory lesion count reductions with DFD-29 vs. placebo. Secondary outcomes included comparisons between DFD-29 and doxycycline in coprimary outcomes and between DFD-29 and placebo in erythema reduction.

IGA treatment success rates were significantly higher with DFD-29 vs. placebo in MVOR-1 (treatment difference [TD], 32.9, 95% confidence interval [CI], 19.6–46.2; p<0.001) and MVOR-2 (TD, 34.1%, 95% CI, 21.3–46.8; p<0.001). The same was true when compared with doxycycline (MVOR-1: TD, 18.0%, 95% CI, 5.0–31.1; p=0.01; MVOR-2: TD, 28.3%, 95 % CI, 17.4–39.3; p<0.001).

DFD-29 was also associated with reductions in total inflammatory lesions compared with placebo (MVOR-1: TD, −9.2; p<0.001; MVOR-2: TD, −6.8; p<0.001) and doxycycline (MVOR-1: TD, −4.7; p<0.001; MVOR-2: TD, −3.5; p<0.001).

Adverse events (AEs) occurred in 26.4% of participants who received DFD-29, 21.6% of those who received doxycycline, and 35.5 % of those who received placebo in MVOR-1, and in 41.8%, 33.1%, and 36.6%, respectively, in MVOR-2. The most common AEs were nasopharyngitis and COVID-19.

In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benefit profile in the treatment of PPR.

Reference: Bhatia N, Del Rosso J, Stein Gold L, 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;161(5):499–507.