Low-Dose Minocycline Superior in Treating Inflammatory Rosacea

New data presented at 2026 Winter Clinical Hawaii showed DFD-29, a modified low-dose oral minocycline 40 mg, significantly outperformed both placebo and doxycycline 40 mg in the treatment of inflammatory lesions in patients with moderate-to-severe rosacea.

The poster, presented by Zoe Draelos, MD, pooled data from two double-blind, placebo-controlled phase 3 trials conducted in the U.S. and Germany. The study population consisted of 653 adult participants randomized to receive one of two treatments once daily or placebo for 16 weeks (DFD-29: n = 245; doxycycline: n = 246; placebo: n = 162). Efficacy was assessed using the Investigator’s Global Assessment (IGA) and changes in inflammatory lesion counts.

In the U.S. cohort, 62.5% of patients treated with DFD-29 achieved IGA success vs. 29.2% for placebo and 39.3% for doxycycline (P < 0.001 for both). In the German cohort, DFD-29 was more effective than placebo (P = 0.006) and showed a numerical advantage over doxycycline (P = 0.064). DFD-29 also demonstrated reductions in inflammatory lesion counts in both cohorts. Mean lesion count reductions were –19.0 in the U.S. and –19.3 in Germany vs. –12.3 and –7.0 for placebo, respectively. Doxycycline showed lesser reductions of –14.8 in the U.S. and –14.4 in Germany.

Treatment-emergent adverse events (TEAEs) were comparable across all groups. The most frequently reported TEAEs were nasopharyngitis, COVID-19, and headache.

"DFD-29 showed superior efficacy to both placebo and doxycycline 40 mg in treating the inflammatory lesions of rosacea," the authors wrote. "There were no clinically meaningful differences in DFD-29 efficacy versus placebo and doxycycline between geographic regions."

Source: Draelos Z, DuBois J, Weirich O, Bayar S, Sidgiddi S. Efficacy of Oral DFD-29, a Low-Dose Minocycline Formulation, in Patients in Germany and in the US: An Analysis of Two Phase 3 Trials. Presented at: