Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409162
Status:
UNKNOWN
Last Update Posted:
2006-12-08
First Post:
2006-12-07
Brief Title:
Safety and Efficacy Study of a New Device for Tattoo Removal
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
A Prospective Open Label Non Randomized First-In-Man Feasibility Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
NOT_YET_RECRUITING
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:
A new mechanical device is evaluated for tattoo removal comparing two types of needle washing fluids 30 healthy subjects with tattoos will be treated The study hypothesis is that the device can be used to achieve satisfactory tattoo removal
Detailed Description:
The new device Eraser TM uses multiple needles action with a washing fluid to remove tattoos Healthy patients who wish to remove a tattoo will be enrolled The study will test the removal of a small part of the tattoo 5cm2 area Treatment lasts about 20 minutes with local analgesia if needed after which an absorptive bandage is put over the treated area for an hour and removed Treatment may be performed using one of two washing fluids For one of them blood samples for material blood level will be taken before and several times after treatment Pictures of the tattooed area being removed will be taken before and after treatment and at each follow-up evaluation
Follow up evaluations will be performed at 1 week two weeks one month and two months post treatment Overall health and skin condition will be evaluated and the tattoo area will be pictured Efficacy of tattoo removal will be evaluated after two months by visual estimation of the percent area that reacted to treatment and the change in brightness both evaluated on a 1-5 analog scale Depending on the result of tattoo removal and on skin condition the study treatment will be stopped if treatment is successful or may be repeated up to a limit of two additional times if the tattoo was not completely removed
The results of tattoo removal using both washing fluids will be analyzed and compared A result of 3 or more on the brightness change scale will be considered as a successful treatment
Pharmacokinetic data for washing fluid no 2 will be collected and analyzed to provide Cmax and AUC
Follow up evaluations will be performed at 1 week two weeks one month and two months post treatment Overall health and skin condition will be evaluated and the tattoo area will be pictured Efficacy of tattoo removal will be evaluated after two months by visual estimation of the percent area that reacted to treatment and the change in brightness both evaluated on a 1-5 analog scale Depending on the result of tattoo removal and on skin condition the study treatment will be stopped if treatment is successful or may be repeated up to a limit of two additional times if the tattoo was not completely removed
The results of tattoo removal using both washing fluids will be analyzed and compared A result of 3 or more on the brightness change scale will be considered as a successful treatment
Pharmacokinetic data for washing fluid no 2 will be collected and analyzed to provide Cmax and AUC
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HM-AHR-1 Rev 02 | None | None | None |