Safety and Efficacy Study of a New Device for Tattoo Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00409162
Recruitment Status : Unknown
Verified December 2006 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2006
Last Update Posted : December 8, 2006
Hawk Medical Technologies Ltd.
Information provided by:
Assaf-Harofeh Medical Center

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.

Condition or disease Intervention/treatment Phase
Tattoo Healthy Device: Eraser TM device, with washing fluid Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2006
Study Completion Date : October 2007

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00409162

Contact: Ori Nesher 00-1-972-54-6511141

Research & Development Unit, Assaf-Harofeh Medical Center,
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Hawk Medical Technologies Ltd.
Principal Investigator: Shay Efrati, MD Assaf Harofe Medical Center Identifier: NCT00409162     History of Changes
Other Study ID Numbers: HTA 3722; 91/06
HM-AHR-1 Rev. 02
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: December 8, 2006
Last Verified: December 2006

Keywords provided by Assaf-Harofeh Medical Center:
Tattoo removal