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Label indication INDICATIONS AND USE ARESTIN is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN may be used as part of a periodontal maintenance program which includes good oral hygiene and scaling and root planing. FDA label
Also known as Minocycline hydrochloride capsules
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 being developed for the treatment of rosacea, a chronic inflammatory skin condition. Journey Medical Corporation is studying it in a Phase 1 trial. Rosacea is the indication under investigation, and the drug is a small molecule formulation. It is investigational and has not been approved for this use.
Journey Medical Corporation, which trades under the ticker DERM, is developing minocycline for rosacea. The company is the sponsor of the clinical program evaluating this small molecule in patients with the condition. The drug is also known as minocycline hydrochloride capsules.
Minocycline is in Phase 1 development for rosacea. One Phase 1 trial has been completed, and no trials are currently active. The program is investigational and has not been approved by the FDA for rosacea. The completed study enrolled 60 participants in the United States.
Minocycline has been studied in one completed Phase 1 trial, NCT05597462, titled Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks. The trial enrolled 60 healthy adult volunteers in the United States, was randomized, double-blind, and placebo-controlled, and included participants aged 18 years and older.
Yes, minocycline hydrochloride capsules is another name for minocycline as developed by Journey Medical Corporation for rosacea. Both names refer to the same small molecule program. The drug is investigational for rosacea and is being evaluated in a Phase 1 clinical trial.