Safety and Efficacy Study of a New Device for Tattoo Removal - Full Text View

Sponsors and Collaborators:	Assaf-Harofeh Medical Center Hawk Medical Ltd.
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00409162

Purpose

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.

Condition	Intervention
Tattoo Healthy	Device: Eraser TM device, with washing fluid

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

Pigment clearance, as evaluated by image comparison on a 1-5 analog scale
Rate of systemic and dermatologic adverse events
Pharmacokinetic data for washing fluid (Cmax and AUC)

Estimated Enrollment:	30
Study Start Date:	December 2006
Estimated Study Completion Date:	October 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409162

Contacts

Contact: Ori Nesher

00-1-972-54-6511141

ori@hawkmedical.com

Locations

Israel
Research & Development Unit, Assaf-Harofeh Medical Center,
Zerifin, Israel, 70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Hawk Medical Ltd.

Investigators

Principal Investigator:

Shay Efrati, MD

Assaf Harofe Medical Center

More Information

No publications provided

Study ID Numbers:	HTA 3722; 91/06, HM-AHR-1 Rev. 02
Study First Received:	December 7, 2006
Last Updated:	December 7, 2006
ClinicalTrials.gov Identifier:	NCT00409162 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

Tattoo removal

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 01, 2009