NCT05597462

Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks

A Randomized, Double-blind Trial Evaluating the Effects of Treatment With DFD-29 Capsules 40 mg QD in Comparison to Placebo on Microbial Flora in Healthy Adult Human Subjects, When Administered Over a Period of 16 Weeks.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Journey Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

A multi-center (up to three sites), randomized, double-blind, placebo-controlled, parallel group trial with a treatment period of 16 weeks. Sixty (60) healthy adult human subjects will be randomized in a 2:1 ratio to receive treatment with DFD-29 (Minocycline Hydrochloride Capsules) 40 mg QD orally or matching Placebo (for DFD-29 capsules) QD orally for a period of 16 weeks. The trial will have a screening period (Day -30 to Day -1) and a trial treatment period (Day 1 to Day 113). There will be 6 planned visits to the study site for subjects. Impact on microbial flora will be assessed from skin swabs, stool samples and vaginal swabs (female subjects) taken at multiple timepoints.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Minocycline hydrochloride capsules	Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks.
OTHER	Placebo	Placebo capsules will be administered orally once daily for 16 weeks.

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2022-10-28
• Last updated: 2023-08-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study