Safety and Efficacy Study of a New Device for Tattoo Removal

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Hawk Medical Ltd.
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00409162
First received: December 7, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Assaf-Harofeh Medical Center:
Tattoo removal

ClinicalTrials.gov processed this record on October 01, 2014