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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01773122 | Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris | PHASE1 | COMPLETED | 77 | — | — | Jan 21, 2013 | May 5, 2013 | Apr 24, 2019 | 1 | United States |
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.
| Arm | Type | Description |
|---|---|---|
| Dapsone Formulation A | EXPERIMENTAL | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone Formulation B | EXPERIMENTAL | Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone Formulation C | EXPERIMENTAL | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone 5% Gel | ACTIVE_COMPARATOR | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Name | Type | Description |
|---|---|---|
| Dapsone Formulation A | DRUG | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone Formulation B | DRUG | Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone Formulation C | DRUG | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Dapsone 5% Gel | DRUG | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
Inclusion Criteria: * Diagnosis of acne vulgaris * Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study * If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the...