Study Stopped
Sponsor decided that the results were not significant enough to continue.
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
1 other identifier
interventional
8
1 country
1
Brief Summary
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
1 active site
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
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 16, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
December 21, 2012
CompletedDecember 21, 2012
November 1, 2012
1 year
January 16, 2012
November 9, 2012
November 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tattoo Removal Efficiency
Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit: 1. Scoring by independent dermatologist 2. Measuring pigment clearance using image analysis
6 months (termination)
Secondary Outcomes (1)
Tolerability Score
0, 2, 4, 6, 8, 10 weeks (after every treatment)
Study Arms (1)
Treatment
EXPERIMENTALCupola Tattoo Removal Device
Interventions
Up to 6 treatments with the device every 2-3 weeks to the tattoo area.
Eligibility Criteria
You may qualify if:
- Tattoos
- Age of tattoo - more than 1 year since application
- Type - decorative (not cosmetic)
- Not previously treated
- General
- At least 18 years of age
- Agrees to sign the Informed Consent
- Willingness to remove tattoo
- Willingness to have photographs and color measurements of the treated area taken and to be used for marketing and educational presentation and/or publications
- Willingness to follow the treatment schedule and post treatment care requirement for tattooing and removal
- Not planning to remove the tattoo in a different procedure during the time of the experiment
You may not qualify if:
- Skin conditions
- Skin type 5 and 6
- History of keloid formation
- Active herpes simplex
- Psoriasis or vitiligo
- Other medical conditions
- HIV or Hepatitis
- Pregnancy or intention to become pregnant in the next 6 months
- No allergic reaction during the tattooing process.
- Medication
- Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive
- Taking isotretinoin (Accutane) currently or within the last 6 months
- Minocyclin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr David Friedman Laser & Skin Center, Diskin 60 st.
Jerusalem, Israel
Results Point of Contact
- Title
- David J. Friedman, Principal Investigator
- Organization
- Dr David Friedman Laser & Skin Center
Study Officials
- PRINCIPAL INVESTIGATOR
David J Friedman, M.D.
Friedman Skin & Laser Center
- STUDY DIRECTOR
Lilach Gavish, Ph.D.
Friedman Skin & Laser Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2012
First Posted
January 24, 2012
Study Start
November 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
December 21, 2012
Results First Posted
December 21, 2012
Record last verified: 2012-11