Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

Summary

The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)

Timeline

Start

2009-08

Primary completion

2010-03

Completion

2010-03

Outcome

Missed primary endpoint

registry Visonac Cream With PDT vs Vehicle Cream With PDT; p = 0.0703; Odds Ratio (OR) 6.43 (95% CI 0.65 to 63.18) NCT00933543 ↗

registry Visonac Cream With PDT vs Vehicle Cream With PDT; p = 0.2969; Mean Difference (Net) -3.92 (95% CI -11.35 to 3.50) NCT00933543 ↗

registry Visonac Cream With PDT vs Vehicle Cream With PDT; p = 0.8913; Mean Difference (Net) 0.67 (95% CI -9.09 to 10.43) NCT00933543 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Visonac	Unknown	—	Topical

Indications