A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
Summary
This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-04
- Completion
- 2012-05
Outcome
Met primary endpoint
registry Vehicle Cream With PDT vs Visonac Cream With PDT; p = 0.006; Difference in least square means -7.35 (95% CI -12.5 to -2.2); ANCOVA NCT01347879 ↗
release “the results of the phase 2b study in acne with Visonac (methyl aminolevulinate 80mg/g), a novel topical acne treatment. In this study, Visonac showed a statistically significant reduction” photocure.com ↗
release “The primary efficacy end-point in the study, reduction of inflammatory acne lesions, was achieved.” photocure.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Visonac | Unknown | — | Topical |