Trial Outcomes & Findings for The Efficacy of the Cupola Ultrasonic Tattoo Removal Device (NCT NCT01516034)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

6 months (termination)

Results posted on

2012-12-21

Participant Flow

Recruitment period: 20-Nov-2011 to 11-Mar-12 Location: Dermatological clinic

Participant milestones

Participant milestones
Measure	Treatment Cupola tattoo removal treatment
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Cupola tattoo removal treatment
Overall Study Physician Decision	1
Overall Study Lack of Efficacy	7

Baseline Characteristics

The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=8 Participants Cupola tattoo removal treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	32.1 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment Israel	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months (termination)

Population: The number of participants that completed follow up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 2, 4, 6, 8, 10 weeks (after every treatment)

The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=8 participants at risk Cupola tattoo removal treatment
Skin and subcutaneous tissue disorders Mild thickening of the skin	25.0% 2/8 • Number of events 2

Additional Information

David J. Friedman, Principal Investigator

Dr David Friedman Laser & Skin Center

Phone: +972-2-5635673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60