Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06090721 | DMT310-009 Topical in the Treatment of Acne Vulgaris | PHASE3 | COMPLETED | 520 | — | — | Dec 8, 2023 | Apr 30, 2025 | Aug 22, 2025 | 2 | United States |
| NCT04106778 | DMT310-003 Topical in the Treatment of Acne Vulgaris | PHASE2 | COMPLETED | 181 | — | — | Oct 10, 2019 | May 4, 2020 | Jul 22, 2020 | 1 | United States |
| NCT03536637 | DMT310-001 Topical in the Treatment of Acne Vulgaris | PHASE2 | COMPLETED | 121 | — | — | May 22, 2018 | Jan 28, 2019 | Jul 22, 2020 | 9 | United States |
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...