Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
This is a clinical research study to determine the ability of the Clear device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as describe in the operator manual.
The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in which the subjects will be treating themselves with the Clear device, and 2 follow-up visits to evaluate the results. The clinical result will be assessed by the investigator for improvement in the acne condition. Treatment will be performed on the face of subjects enrolled and who meet the inclusion criteria.
Monitor Acne Lessions Count Reduction as Result of Usinfg the Device
Device: light based device for treatment of acne
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for the Treatment of Mild to Moderate Inflammatory Acne.|
- Acne lession count [ Time Frame: 3 months post treatment ] [ Designated as safety issue: No ]acne count post treatment compared to based line count
|Study Start Date:||November 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: lession count reduction post treatment
||Device: light based device for treatment of acne|
The subjects will be recruited if they are eligible to participate in the study according with the device labeling presented at the doctor's office by printed ads. Subjects will be given information about the Clear device according to its labeling. After reading the information and labeling, it will be the subjects' decision if they understand the device label information and if they want to participate in the study. The investigator will review the inclusion / exclusion criteria with the subjects to ensure eligibility.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678482
|Toronto, Ontario, Canada, M5R3N8|