RosaceaPhase 1NCT05597462
Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks
A Phase 1 study testing Minocycline hydrochloride capsules in people with Rosacea, run by Journey Medical Corporation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Minocycline hydrochloride capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2022to 30 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating female aged ≥ 18 and ≤ 65 years.
- Subjects must have understood, and signed IRB/IEC approved written ICF.
- Subjects must be willing to refrain from using all other antibiotics during the 16-week treatment period, other than the IP.
- Women of childbearing potential* must not be pregnant or lactating at the time of screening visit as documented by a negative urine pregnancy test.
- 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.
- 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.
- 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.
Who cannot join
- Female subjects who are pregnant, lactating or planning to become pregnant during trial participation.
- History of allergy or known sensitivity to minocycline, doxycycline, other tetracycline, or any component of the study medication.
- 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
- History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
- History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
- 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.
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- Subjects with an active acute or chronic systemic infections
- Subjects with planned surgery during the trial or within 30 days after the last dose administration
- Subjects who cannot avoid excessive exposure to UV radiation (use of tanning booths or extended /occupational exposure to sunlight)
- Subjects that have a medical history of photosensitivity or hyperpigmentation
- 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
- Subjects who used the following
- Non-tetracycline antibiotics (systemic) within 6 weeks prior to Baseline (BL)
- Tetracycline antibiotics (systemic) within 3 months prior to BL
- 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
- 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
- Subjects who are on anti-coagulants or those likely to require anti-coagulants during the trial period
- Subjects who have used methoxyflurane or other nephrotoxic drugs (in the opinion of the Investigator) within the past 30 days of BL
- Subjects who have used topical retinoids or topical antibiotics to the face 30 days prior to BL
- Subjects who have used on their facial skin within 30 days prior to BL topical corticosteroids, topical anti-mycotic, topical azelaic acid or ivermectin
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
3A Research, LLC
El Paso, Texas, 79925
3A Research, LLC
Las Cruces, New Mexico, 88011
About this study
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.
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.
Read the 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
- Being tested
- Minocycline hydrochloride capsules, Placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline hydrochloride capsulesDrug
Also called DFD-29
Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks.
PlaceboOther
Also called Placebo comparator
Placebo capsules will be administered orally once daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DFD-29 | Experimental | DFD-29 (minocycline hydrochloride) capsules, 40 mg will be administered orally once daily for 16 weeks. Receives: Drug: Minocycline hydrochloride capsules |
| Placebo | Placebo comparator | Placebo capsules will be administered orally once daily for 16 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline to Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start30 Sep 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-center, randomized, double-blind, placebo-controlled, parallel group trial with a treatment period of 16 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Journey Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Responsible party
- Sponsor
- Investigators
- Srinivas Sidgiddi, M.D., Study director, Journey Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597462
- Sponsor's protocol ID
- DFD-29-CD-006
- Status last verified
- Aug 2023
- First submitted
- 24 Oct 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will comply with the HIPAA regulations in this matter.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05597462
- Acronym / sponsor ID
- DFD-29-CD-006
- Conditions
- Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Journey Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multi-center, randomized, double-blind, placebo-controlled, parallel group trial with a treatment period of 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| DFD-29 | Experimental | Drug: Minocycline hydrochloride capsulesDFD-29 (minocycline hydrochloride) capsules, 40 mg will be administered orally once daily for 16 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules will be administered orally once daily for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or non-pregnant, non-lactating female aged ≥ 18 and ≤ 65 years.
- Subjects must have understood, and signed IRB/IEC approved written ICF.
- Subjects must be willing to refrain from using all other antibiotics during the 16-week treatment period, other than the IP.
- Women of childbearing potential* must not be pregnant or lactating at the time of screening visit as documented by a negative urine pregnancy test.
- 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.
Key exclusion criteria (22 listed)
- Female subjects who are pregnant, lactating or planning to become pregnant during trial participation.
- History of allergy or known sensitivity to minocycline, doxycycline, other tetracycline, or any component of the study medication.
- 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
- History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
- History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline hydrochloride capsulesAlso: DFD-29Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks. | Drug | DFD-29 |
| PlaceboAlso: Placebo comparatorPlacebo capsules will be administered orally once daily for 16 weeks. | Other | Placebo |
Primary outcome
Changes in the number of colony forming units (CFUs) of microbial species.
Time frame: Baseline to Week 16
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
Changes in MIC90 of selected colonized microbial species.
Time frame: Baseline to Week 16.
Changes in MIC90 of the selected colonized microbial species to minocycline in the comparison of DFD-29 group versus Placebo treatment groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Yes. We will comply with the HIPAA regulations in this matter.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas Sidgiddi, M.D. study director
Journey Medical Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minocycline hydrochloride capsules in people with Rosacea, run by Journey Medical Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the number of colony forming units (CFUs) of microbial species. (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.