Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DMT310 · 3 trials · 1 indication
Inflammatory and Noninflammatory
0 Clear No evidence of facial acne vulgaris 1. Almost Clear Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 4. Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present
| Arm | Type | Description |
|---|---|---|
| DMT310 Topical Powder | EXPERIMENTAL | DMT310 Powder mixed with Hydrogen Peroxide |
| Placebo Topical Powder | EXPERIMENTAL | Placebo powder mixed with Hydrogen Peroxide |
| Study Treatment 1 | EXPERIMENTAL | DMT310 Powder mixed with Hydrogen Peroxide |
| Study Treatment 2 | EXPERIMENTAL | Placebo powder mixed with Hydrogen Peroxide |
| Study Treatment 3 | EXPERIMENTAL | Placebo powder mixed with Hydrogen Peroxide |
| Control | PLACEBO_COMPARATOR | Placebo powder mixed with Placebo Diluent |
| Name | Type | Description |
|---|---|---|
| DMT310 | DRUG | Topical Powder |
| Placebo | DRUG | Placebo Topical Powder |
| Hydrogen Peroxide | DRUG | Liquid Diluent |
Inclusion Criteria: * Patient sex at birth, male or non-pregnant female at least 9 years of age * Clinical diagnosis of moderate to severe acne vulgaris as determined by: Investigator's Global Assessment (IGA) at Randomization; Patient has at least 20 inflammatory lesions and at least 20 noninflam...
DMT310 is an investigational small molecule topical drug being developed for the treatment of acne vulgaris. It is currently in Phase 3 clinical development and is not yet approved by the FDA. The drug is being studied in patients as young as 9 years old.
DMT310 is being developed by Dermata Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DRMA. The company is conducting clinical trials of DMT310 as a topical treatment for acne vulgaris.
DMT310 is currently in Phase 3 clinical development. The most advanced trial, NCT06090721, is a Phase 3 study that has been completed with 520 participants. DMT310 is investigational and has not received FDA approval.
DMT310 has been studied in three completed clinical trials: NCT03536637 (Phase 2, 121 participants), NCT04106778 (Phase 2, 181 participants), and NCT06090721 (Phase 3, 520 participants). All trials were conducted in the United States for acne vulgaris.
No, DMT310 is not FDA approved. It is an investigational drug currently in clinical development for acne vulgaris. The Phase 3 trial has been completed, but the drug has not yet received regulatory approval.