Dr. Reddy's Laboratories Ltd. (Russia)

The purpose of this trial is to evaluate the effects of 16-week treatment with DFD-29 40 mg QD dose in comparison to Placebo on the skin, intestinal and vaginal microbiota.

Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.

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.