Conditions: Acne Vulgaris
Keywords: Acne vulgaris PDT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 153
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: active treatment with light dose of 37 Joule/cm2 arm 2: Placebo treatment, Light dose 37 Joule/cm2

Interventions: intervention 1: Visonac PDT intervention 2: Vehicle cream with PDT
Intervention descriptions: intervention 1: cream application prior to illumination with red light intervention 2: placebo/vehicle cream application prior to illumination with red light

Protocol document: