Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102343
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-18
Brief Title:
Safety and Efficacy Investigation on the Effects of ClearSkin Non-ablative ERGlass 1540nm Laser Module in the Treatment of Acne Scars
Sponsor:
Alma Lasers
Organization:
Alma Lasers
Study Overview
Official Title:
Open-label Safety and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER Glass 1540nm Laser Module in the Treatment of Acne Scars
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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 ClearSkin module Er Glass 1540nm is largely used in the treatment of acne vulgaris and acne scars The non-ablative ERGlass 1540 nm laser deeply penetrates the skin causing thermal damage to the sebaceous glands destroying P acnes bacteria and reducing sebum production while leaving the epidermis intact The integrated vacuum mechanism extracts accumulated sebaceous material from the pores while contact cooling protects the skin reducing pain and allowing for safer and more effective treatment of the sebaceous glands within the dermis Based on this background the investigators have considered a pilot study aimed at assessing the efficacy and safety of the ClearSkin Module in treating subjects with facial acne scars
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None