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.

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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Minocycline hydrochloride capsules; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Las Cruces, New Mexico, United States, 88011
      • 3A Research, LLC
  • Texas
    • El Paso, Texas, United States, 79925
      • 3A Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female aged ≥ 18 and ≤ 65 years.
2. Subjects must have understood, and signed IRB/IEC approved written ICF.
3. Subjects must be willing to refrain from using all other antibiotics during the 16-week treatment period, other than the IP.
4. Women of childbearing potential* must not be pregnant or lactating at the time of screening visit as documented by a negative urine pregnancy test.
5. Women of childbearing potential must be willing to use an acceptable form of birth control during the trial from the day of the first dose administration to 30 days after the last administration of trial drug.
6. All male subjects must agree to use accepted methods of birth control with their partners, throughout the study and until 30 days after the last administration of trial drug.
7. Subjects must be in good health and free from any clinically significant disease, which may interfere with the evaluation of microbiota or the administration of the IP.

Exclusion Criteria:

1. Female subjects who are pregnant, lactating or planning to become pregnant during trial participation.
2. History of allergy or known sensitivity to minocycline, doxycycline, other tetracycline, or any component of the study medication.
3. Clinically significant abnormal laboratory test results that, in the opinion of the Investigator, would compromise the subject's safety or ability to participate in the trial
4. History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
5. History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
6. Any clinically significant condition that, in the opinion of the Investigator, would interfere with the study evaluations or would place the trial subject at undue safety risk.
7. Subjects with an active acute or chronic systemic infections
8. Subjects with planned surgery during the trial or within 30 days after the last dose administration
9. Subjects who cannot avoid excessive exposure to UV radiation (use of tanning booths or extended /occupational exposure to sunlight)
10. Subjects that have a medical history of photosensitivity or hyperpigmentation
11. Female subjects with medical history within 3 months prior to randomization of having vaginitis or that use a vaginal douche or vaginal cleaning agent within 48 hours of any visit

12. Subjects who used the following

    1. Non-tetracycline antibiotics (systemic) within 6 weeks prior to Baseline (BL)
    2. Tetracycline antibiotics (systemic) within 3 months prior to BL
13. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates) within one year prior to screening
14. Subjects who have been treated with systemic retinoids or therapeutic Vitamin A supplements > 10,000 IU/ day (multivitamin tablets are allowed) within 180 days prior to the BL
15. Subjects who are on anti-coagulants or those likely to require anti-coagulants during the trial period
16. Subjects who have used methoxyflurane or other nephrotoxic drugs (in the opinion of the Investigator) within the past 30 days of BL
17. Subjects who have used topical retinoids or topical antibiotics to the face 30 days prior to BL
18. Subjects who have used on their facial skin within 30 days prior to BL topical corticosteroids, topical anti-mycotic, topical azelaic acid or ivermectin
19. Subjects who have participated in an investigational drug trial (i.e., subjects have been treated with an investigational drug) within 30 days prior to BL or where sufficient washout period has not been achieved; whichever period is longer.
20. Subjects having symptoms of COVID-19 or have had close contact with someone with suspected or confirmed SARS-CoV-2 infection within 10 days prior to screening or who are at high risk of SARS-CoV-2 infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFD-29; DFD-29 (minocycline hydrochloride) capsules, 40 mg will be administered orally once daily for 16 weeks.	Drug: Minocycline hydrochloride capsules; Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks.; Other Names: DFD-29
Placebo Comparator: Placebo; Placebo capsules will be administered orally once daily for 16 weeks.	Other: Placebo; Placebo capsules will be administered orally once daily for 16 weeks.; Other Names: Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the number of colony forming units (CFUs) of microbial species.	Change in the colony forming units (CFUs) of microbial species colonized from skin, gastrointestinal or vaginal swabs from Baseline (BL) to Week 16 in comparison of DFD-29 versus Placebo treatment groups	Baseline to Week 16
Changes in MIC90 of selected colonized microbial species.	Changes in MIC90 of the selected colonized microbial species to minocycline in the comparison of DFD-29 group versus Placebo treatment groups.	Baseline to Week 16.

Collaborators and Investigators

• Sponsor: Journey Medical Corporation
• Collaborators: Dr. Reddy's Laboratories Limited
• Investigators: Study Director: Srinivas Sidgiddi, M.D., Journey Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: DFD-29-CD-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will comply with the HIPAA regulations in this matter.
• IPD Sharing Time Frame: Before database lock for the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No