Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02910492
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of a Novel Laser for Skin Rejuvenation
Sponsor:
Cutera Inc.
Organization:
Study Overview
Official Title:
A Single-Center, Open-Label Exploratory Study of a Novel Laser for Skin Rejuvenation
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Single-center study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.
Detailed Description:
A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.
Subjects will receive laser treatments, and will be followed at 12 weeks post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up.
Subjects will receive laser treatments, and will be followed at 12 weeks post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up.
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?: