An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
|ClinicalTrials.gov Identifier: NCT00811161|
Recruitment Status : Unknown
Verified June 2009 by PerfAction Ltd..
Recruitment status was: Recruiting
First Posted : December 18, 2008
Last Update Posted : June 4, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Wrinkles or Damaged Skin Condition||Device: Airgent||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||April 2010|
|Experimental: needle free injector of HA||
HA needle free injection, 3-4 treatments, 3-4 weeks apart
- Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation. [ Time Frame: 3-12 months ]
- recording of adverse events. [ Time Frame: 1-3 month ]
- Evaluate subjects' satisfactory of the treatment [ Time Frame: 1-12 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811161
|Contact: Dean D. AD-EL, MD||+972 3 937 firstname.lastname@example.org|
|Rabin Medical Center||Recruiting|
|Petah Tiqwa, Israel|
|Contact: Dean D. AD-EL, MD +972 3 937 6366 email@example.com|
|Principal Investigator: Dean AD-EL, MD|
|Sub-Investigator: Oren Ganor, MD|
|Principal Investigator:||Dean D. AD-EL D. AD-EL, MD||Rabin Medical Center|