Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:55 AM
Study NCT ID:
NCT05202834
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on Human Skin
Sponsor:
FA Corporation
Organization:
Study Overview
Official Title:
Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on Human Skin
Status:
COMPLETED
Status Verified Date:
2022-01
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:
Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on human skin
Detailed Description:
The study is being conducted to evaluate the safety and efficacy of the UltraClear Mid IR Fiber Laser Workstation using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis. Epidermis is the skin most outer layer that is supported by the dermis, which is the thick layer of living tissue below the epidermis which forms the true skin, containing blood capillaries, nerve endings, sweat glands, hair follicles, and other structures. Superficial ablative properties of the laser are the ability to remove thin and controlled layer of epidermis without damaging the underlaying layers of the skin, while the deep ablative properties of the laser are the ability to create a controlled and consistent mechanical and thermal injury in the skin that will lead to strong healing process that will improve the skin properties such as softness, elasticity and appearance. Round ø4.0 mm ( \~ø 1/8") Biopsies will be taken to examine the histologic effects of the treatments.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: