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

Rosacea Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05597462
Study type Interventional
Source Journey Medical Corporation
Contact
Status Completed
Phase Phase 1
Start date September 30, 2022
Completion date May 30, 2023
View Details
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