Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00933543
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2009-07-02
Brief Title:
Efficacy and Safety Study With Visonac Photodynamic Therapy PDT
Sponsor:
Photocure
Organization:
Photocure
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 lightdose 37Jcm2
Detailed Description:
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 Investigators 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None