Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 4:23 AM
Study NCT ID:
NCT01847066
Status:
UNKNOWN
Last Update Posted:
2013-05-06
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidermal Delivery of Ani-Aging Ingredients
Sponsor:
Alma Lasers Inc.
Organization:
Study Overview
Official Title:
Fractional Erbium 2940nm Laser & Impact US for Trans-Epidermal Delivery of Cosmetic Anti-Aging Ingredients for Wrinkles, Acne Scars and Pigmented Skin: A Randomized Split Face & Dorsal Hand Side by Side Study
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
ENROLLING_BY_INVITATION
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:
To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and pigmented skin.
Detailed Description:
This is a randomized, split face \& dorsal hand side by side study. The purpose of the side by side study is to determine whether the use of the Impact with the ablative fractional 2940nm laser and cosmetics improves the cosmetic outcomes when compared to using just the ablative fractional 2940nm laser with the cosmetics.
This is a non-significant risk aesthetic clinical study. Only cosmetic formulations will be used during the study, These cosmetic formulations do not contain any ingredient categorized as a drug by the FDA.
This is a non-significant risk aesthetic clinical study. Only cosmetic formulations will be used during the study, These cosmetic formulations do not contain any ingredient categorized as a drug by the FDA.
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?: