Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT00811161
Status:
UNKNOWN
Last Update Posted:
2009-06-04
First Post:
2008-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Sponsor:
PerfAction Ltd.
Organization:
Study Overview
Official Title:
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: