Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CB-03-01 · 1 trial · 1 indication
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
| Arm | Type | Description |
|---|---|---|
| Low-dose active, BID | EXPERIMENTAL | low dose of CB-03-01, 0.1% applied twice a day |
| Medium-dose active, BID | EXPERIMENTAL | medium dose of CB-03-01, 0.5% applied twice a day |
| High-dose active, QD | EXPERIMENTAL | high dose of CB-03-01, 1% applied once a day |
| High-dose active, BID | EXPERIMENTAL | high dose of CB-03-01, 1% applied twice a day |
| Vehicle, QD or BID | PLACEBO_COMPARATOR | vehicle cream, applied once or twice a day |
| Name | Type | Description |
|---|---|---|
| CB-03-01 | DRUG | Topical cream, applied once a day |
| Vehicle | DRUG | Topical cream, applied once or twice a day |
Inclusion Criteria: * Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods. * Subject has provided written and verbal informed consent/assent. * Subject has facial acne vulgaris (including the nose). * Subject is...
CB-03-01 is an investigational small molecule being developed for the treatment of acne vulgaris. It is a topical cream formulation intended for facial acne. The drug is currently in clinical development and has not been approved by the FDA.
CB-03-01 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for acne vulgaris.
CB-03-01 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under investigation for the treatment of acne vulgaris.
CB-03-01 has one completed clinical trial, identified as NCT01631474. This was a Phase 2 dose-escalating study evaluating the safety and efficacy of CB-03-01 cream in subjects with facial acne vulgaris. The trial enrolled 363 participants in the United States.
CB-03-01 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being studied specifically as a topical cream for the treatment of acne vulgaris.