Status:
UNKNOWN
Safety and Efficacy Study of a New Device for Tattoo Removal
Lead Sponsor:
Assaf-Harofeh Medical Center
Collaborating Sponsors:
Hawk Medical Technologies Ltd.
Conditions:
Tattoo
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 smal...
Eligibility Criteria
Inclusion
- Male or female subjects 18 years or older, of any race
- Subject has a tattoo for removal on the back, shoulders or abdomen (areas that can usually be hidden)
- Subjects willing to participate as evidenced by signing the written informed consent
Exclusion
- Subject has a dermatological disease, active or latent (e.g. psoriasis)
- Subject has a known tendency for Keloid formation.
- Subject has a known tendency for skin hyperpigmentation.
- Subject is susceptible to Koebner reaction.
- Subject has blood transmittable diseases (HIV, HBV, HCV, etc.)
- Subject has known allergy to device components/ treatment fluids
- Subject has medical conditions that may be worsened by concomitant use of washing fluid, or worsened by local anesthesia materials.
- Subject is taking certain medications or topical preparations.
- Female subject who is pregnant or lactating.
- Subject participating in any other clinical study at the same time
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00409162
Start Date
December 1 2006
End Date
October 1 2007
Last Update
December 8 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research & Development Unit, Assaf-Harofeh Medical Center,
Ẕerifin, Israel, 70300