Wrinkles or Damaged Skin Condition Clinical Trial
Official title:
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment