An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Recruitment status was: Recruiting
The primary objective of this study is to Evaluate the effectiveness of treatment of wrinkles or damaged skin with the Airgent device.
The secondary objective of this study are to:
- Evaluate subjects' satisfactory of the treatment.
- Demonstrate the safety of the Airgent treatment by evaluation of adverse events.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin|
- Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation. [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]
- recording of adverse events. [ Time Frame: 1-3 month ] [ Designated as safety issue: Yes ]
- Evaluate subjects' satisfactory of the treatment [ Time Frame: 1-12 month ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||April 2010|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Experimental: needle free injector of HA||
HA needle free injection, 3-4 treatments, 3-4 weeks apart
Each subject will attend the clinic for the screening visit, 3 or 4 treatment visits 3-4 weeks apart, and number of follow-up visits (three at least). Evaluation of results of the performed treatments will be performed in course of the next treatment visit (prior to performance the next treatment) and at follow-up visits at 1, 3 and 6 months after the last treatment in session. Additional evaluation visits at 9 and 12 months after completion the treatment session can be performed upon decision of the investigator in case when considerable improvement is recorded during the 6-months evaluation visit.
Biopsies from up to five subjects treated for stretch marks will be collected at the time of 3-months evaluation visit, from treated and untreated zone (one of each).
Subjects will be requested to refrain from using any other method of skin rejuvenation for the entire duration of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811161
|Rabin Medical Center|
|Petah Tiqwa, Israel|
|Principal Investigator:||Dean D. AD-EL D. AD-EL, MD||Rabin Medical Center|