Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 3:18 AM
Study NCT ID:
NCT01973166
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2013-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
Sponsor:
Cutera Inc.
Organization:
Study Overview
Official Title:
Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal
Status:
COMPLETED
Status Verified Date:
2023-01
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:
The purpose of this study is to compare the investigational medical grade laser device to a marketed medical grade laser device for effectiveness in lightening or clearing unwanted tattoos. This study will also compare any side effects from treatment with the devices.
Detailed Description:
This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks).
The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.
The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.
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?: