Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-05 @ 6:14 PM
Study NCT ID:
NCT02818556
Status:
UNKNOWN
Last Update Posted:
2016-06-29
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines
Sponsor:
The Maas Clinic
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-06
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:
This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical perioral lines. Injections will be performed at the baseline visit. To ensure subject and investigator blinding, syringes will be prepared and labeled "1" and "2" immediately before subject attendance for injection by the sub-investigator. The same injection sites and techniques will be used on both sides of the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150, 180.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: