Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Minocycline · 1 trial · 1 indication
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 the selected colonized microbial species to minocycline in the comparison of DFD-29 group versus Placebo treatment groups.
| Arm | Type | Description |
|---|---|---|
| DFD-29 | EXPERIMENTAL | DFD-29 (minocycline hydrochloride) capsules, 40 mg will be administered orally once daily for 16 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules will be administered orally once daily for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Minocycline hydrochloride capsules | DRUG | Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks. |
| Placebo | OTHER | Placebo capsules will be administered orally once daily for 16 weeks. |
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. W...
Minocycline is a small molecule being developed for the treatment of rosacea. It is currently in Phase 1 clinical development as an investigational therapy for this dermatological condition. The drug is being studied for its effects on the microbial flora of healthy adult subjects over a 16-week administration period.
Minocycline is being developed by Journey Medical Corporation, a biopharmaceutical company. The company is publicly traded under the ticker symbol DERM. Journey Medical is conducting clinical research to evaluate the drug's potential as a treatment for rosacea.
Minocycline is in Phase 1 clinical development. A Phase 1 clinical trial has been completed to evaluate the drug's impact on microbial flora in healthy adult subjects. The drug is investigational and has not yet been approved by regulatory authorities for the treatment of rosacea.
Minocycline has one completed clinical trial registered under NCT05597462. The study, titled "Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks," was a Phase 1, randomized, double-blind, placebo-controlled trial conducted in the United States with 60 participants.
Yes, Minocycline is also known as DFD-29. The clinical trial NCT05597462 refers to the drug as DFD-29, which is the same compound being developed by Journey Medical Corporation for rosacea. This alternative name is used in clinical research documentation.