Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Summary
This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.
Timeline
- Start
- 2007-02
- Primary completion
- 2008-07
- Completion
- 2008-09
Outcome
Missed primary endpoint
registry analysis (superiority or other test); 40 mg/g MAL PDT vs Vehicle PDT; p = 0.5288; % success rate 5.53 (95% CI -7.97 to 19.04) NCT00594425 ↗
registry analysis (superiority or other test); 40 mg/g MAL PDT vs Vehicle PDT; p = 0.3236; Least squares mean -2.64 (95% CI -7.91 to 2.63) NCT00594425 ↗
registry analysis (superiority or other test); 40 mg/g MAL PDT vs Vehicle PDT; p = 0.7889; %success rate 3.09 (95% CI -11.16 to 17.33) NCT00594425 ↗
registry analysis (superiority or other test); 40 mg/g MAL PDT vs Vehicle PDT; p = 0.9151; Least squares mean -0.33 (95% CI -6.53 to 5.86) NCT00594425 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | methyl aminolevulinate | Small molecule | 40 unknown | Topical |
| Subject | methyl aminolevulinate | Small molecule | 80 unknown | Topical |