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

NCT05597462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-02

No results posted yet for this study

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.

Conditions

  • Rosacea

Interventions

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.

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    collaborator INDUSTRY

  • Journey Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Srinivas Sidgiddi, M.D. · Journey Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-05-30
Completion
2023-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05597462 on ClinicalTrials.gov