Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT00811161
Brief Summary:
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.
Detailed Description:
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:
NCT00811161
Study Brief:
Protocol Section:
NCT00811161