NCT00409162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 8, 2006

Status Verified

December 1, 2006

First QC Date

December 7, 2006

Last Update Submit

December 7, 2006

Conditions

TattooHealthy

Keywords

Tattoo removal

Outcome Measures

Primary Outcomes (3)

  • 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)

Interventions

Eraser TM device, with washing fluidDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research & Development Unit, Assaf-Harofeh Medical Center,

Ẕerifin, 70300, Israel

Location

Study Officials

  • Shay Efrati, MD

    Assaf Harofe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ori Nesher

CONTACT

00-1-972-54-6511141ori@hawkmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

December 1, 2006

Study Completion

October 1, 2007

Last Updated

December 8, 2006

Record last verified: 2006-12

Locations

IL(1)