Acne Vulgaris Clinical Trial
Official title:
A Double Blinded, Prospective, Randomized, Stratified, Placebo-controlled, Multi-center Study of Photodynamic Therapy With VisonacTM Cream in Patients With Moderate to Severe Acne Vulgaris.
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)
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study
in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to
4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be
classified according to age in the two age groups 9 to 12 years and 13 to 35 years and
randomized to either Visonac or vehicle cream within each age group. All patients will
receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be
done after each treatment and at 12 weeks after the first treatment. Safety evaluations will
be performed at each treatment visit and at 12 weeks after the first treatment.
Photographs of patients will be taken before and after treatment at first and last treatment
visit, and at 12 weeks after first treatment.
Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment
and at one week after last treatment visit.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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