Trial Outcomes & Findings for Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos (NCT NCT02110095)

NCT ID: NCT02110095

Last Updated: 2020-12-11

Results Overview

Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 2 months post last treatment
• Results posted on: 2020-12-11

Participant Flow

Participant milestones

Measure	Picosure Laser System Picosure Laser System for the treatment of unwanted tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
Overall Study STARTED	15
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One of the subjects did not report his/her race/ethnicity.

Baseline characteristics by cohort

Measure	Picosure Laser System n=15 Participants Picosure Laser System for the treatment of unwanted tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants
Sex: Female, Male Female	9 Participants n=15 Participants
Sex: Female, Male Male	6 Participants n=15 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	10 Participants n=14 Participants • One of the subjects did not report his/her race/ethnicity.
Race/Ethnicity, Customized Race/Ethnicity · African American	3 Participants n=14 Participants • One of the subjects did not report his/her race/ethnicity.
Race/Ethnicity, Customized Race/Ethnicity · Asian	1 Participants n=14 Participants • One of the subjects did not report his/her race/ethnicity.
Race/Ethnicity, Customized Race/Ethnicity · Indian	0 Participants n=14 Participants • One of the subjects did not report his/her race/ethnicity.
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	0 Participants n=14 Participants • One of the subjects did not report his/her race/ethnicity.
Fitzpatrick Skin Type Fitzpatrick Skin Type I	2 Participants n=15 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type II	5 Participants n=15 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type III	4 Participants n=15 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type IV	0 Participants n=15 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type V	3 Participants n=15 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type VI	1 Participants n=15 Participants

PRIMARY outcome

Timeframe: 2 months post last treatment

Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.

Outcome measures

Measure	Picosure Laser System n=8 Participants Picosure Laser System for the treatment of unwanted tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
Number of Patients With Tattoo Clearance # of Patients with 20% Improvement	3 Participants
Number of Patients With Tattoo Clearance # of Patients with 30% Improvement	5 Participants

SECONDARY outcome

Timeframe: 2 months post last treatment

This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied.

Outcome measures

Measure	Picosure Laser System n=8 Participants Picosure Laser System for the treatment of unwanted tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
Physician Satisfaction Questionnaire Patients scored a 5 by physician	4 Participants
Physician Satisfaction Questionnaire Patients scored a 4 by Physician	4 Participants

Adverse Events

Picosure Laser System

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Picosure Laser System n=15 participants at risk Picosure Laser System for the treatment of unwanted tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
Nervous system disorders Pain	53.3% 8/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Blistering	46.7% 7/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Erythema	33.3% 5/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Edema	26.7% 4/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Bruising	6.7% 1/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Pinpoint Bleeding	26.7% 4/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Crusting	73.3% 11/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Itching	53.3% 8/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Allergic Reaction	13.3% 2/15 • Adverse events were collected for the study duration, around 19 months.
Skin and subcutaneous tissue disorders Hypopigmentation	13.3% 2/15 • Adverse events were collected for the study duration, around 19 months.

Additional Information

Jamie Trimper

Cynosure

Phone: 800-886-2966

Email: jamie.trimper@cynosure.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
• Publication restrictions are in place

Restriction type: OTHER