Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 11:35 PM
Study NCT ID:
NCT01299103
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2011-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles
Sponsor:
Ellman International
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Open-Label, 3-Arm Parallel Study Comparing the Safety and Efficacy of Single Therapy Versus Double and Triple Therapy Using the Surgitron® Dual RF™ S5 With the Pellevé™ Wrinkle Treatment Handpiece and Pellevé™ Treatment Gel for the Treatment of Moderate Facial Wrinkles in Fitzpatrick Skin Types I - IV
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
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 study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.
Detailed Description:
The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a single treatment and 21 in treatment Group B receiving two treatments) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.
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?: