NCT01347879

A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Photocure · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Visonac PDT	cream application prior to illumination with red light
DRUG	Vehicle cream with PDT	placebo/vehicle cream application prior to illumination with red light

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2011-05-04
• Last updated: 2014-01-16
• Results posted: 2014-01-16

Locations

15 sites across 1 country: United States