Trial Outcomes & Findings for Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos (NCT NCT02103153)

Last Updated: 2021-04-28

Results Overview

Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

1-3 month follow up post each subject's last treatment, an average of 17.5 months

Results posted on

2021-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Picosure Laser System Subjects will be treated with 1064nm, 532nm, or 755nm in combination or individually, depending on the color of the tattoo and the skin type of the subject. Since the purpose of the study is to test the overall clearance of the tattoo, breaking the results down by wavelengths is extraneous information. The primary purpose of the study is not to compare the wavelengths against each other, but rather, to examine the overall clearance created by the Picosure Laser System. Furthermore, each wavelength is designed to target a specific color, so a multi-colored tattoo will have a variety of wavelengths used (in combination and individually), all for the primary objective of indicating overall tattoo clearance.
Overall Study STARTED	44
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Picosure Laser System n=44 Participants Picosure Laser System
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	27 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	9 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Multiple	6 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Score I	4 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Score II	13 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Score III	18 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Score IV	8 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Score V	0 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Score VI	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-3 month follow up post each subject's last treatment, an average of 17.5 months

Population: 12 subjects were lost to follow up, and 5 subjects withdrew consent.

Outcome measures

Outcome measures
Measure	Picosure Laser System n=34 tattoos Picosure Laser System, using a combination of combination or individual frequencies of 532 nm, 755 nm, or 1064 nm.
Tattoo Clearance Percentage Using a Photographic Scale	84.7 percentage of clearance Standard Deviation 16.9

SECONDARY outcome

Timeframe: Baseline and 2 months post last treatment follow up (+/- 1 month)

Population: 12 subjects were lost to follow up, and 5 subjects withdrew consent.

Questionnaires were used to assess Investigator satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0).

Outcome measures

Outcome measures
Measure	Picosure Laser System n=34 tattoos Picosure Laser System, using a combination of combination or individual frequencies of 532 nm, 755 nm, or 1064 nm.
Investigator Satisfaction Number of Tattoo Results Investigator Was Extremely Dissatisfied With	0 tattoos
Investigator Satisfaction Number of Tattoo Results Investigator Was Dissatisfied With	1 tattoos
Investigator Satisfaction Number of Tattoo Results Investigator Was Satisfied With	19 tattoos
Investigator Satisfaction Number of Tattoo Results Investigator Was Extremely Satisfied With	14 tattoos

SECONDARY outcome

Timeframe: Baseline and 2 months post last treatment follow up (+/- 1 month)

Population: 12 subjects were lost to follow up, and 5 subjects withdrew consent.

Questionnaires were used to assess Subject satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0).

Outcome measures

Outcome measures
Measure	Picosure Laser System n=34 tattoos Picosure Laser System, using a combination of combination or individual frequencies of 532 nm, 755 nm, or 1064 nm.
Subject Satisfaction Number of Tattoo Subjects Were Extremely Satisfied With	11 tattoos
Subject Satisfaction Number of Tattoo Subjects Were Dissatisfied With	5 tattoos
Subject Satisfaction Number of Tattoo Subjects Were Extremely Dissatisfied With	1 tattoos
Subject Satisfaction Number of Tattoo Subjects Were Satisfied With	17 tattoos

Adverse Events

Picosure Laser System- 532 nm Wavelength

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Picosure Laser System- 755 nm Wavelength

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Picosure Laser System- 1064 nm Wavelength

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Picosure Laser System- 532 nm Wavelength n=27 participants at risk Picosure Laser System, using a frequency of 532 nm	Picosure Laser System- 755 nm Wavelength n=27 participants at risk Picosure Laser System, using a frequency of 755 nm	Picosure Laser System- 1064 nm Wavelength n=41 participants at risk Picosure Laser System, using a frequency of 1064 nm
Nervous system disorders Pain	85.2% 23/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	77.8% 21/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	75.6% 31/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Erythema	100.0% 27/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	100.0% 27/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	100.0% 41/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Pinpoint Bleeding	74.1% 20/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	81.5% 22/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	56.1% 23/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Edema	85.2% 23/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	88.9% 24/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	82.9% 34/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Crusting	59.3% 16/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	51.9% 14/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	48.8% 20/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Scabbing	96.3% 26/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	96.3% 26/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	92.7% 38/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Blistering	81.5% 22/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	77.8% 21/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	78.0% 32/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Hypopigmentation	22.2% 6/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	22.2% 6/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	19.5% 8/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Hyperpigmentation	14.8% 4/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	11.1% 3/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	12.2% 5/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Itching	29.6% 8/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	18.5% 5/27 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	29.3% 12/41 • Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Additional Information

Jamie Trimper

Cynosure

Phone: 800-886-2966

Email: [email protected]

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