Trial Outcomes & Findings for Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars (NCT NCT02103127)

Last Updated: 2021-01-15

Results Overview

The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 1 month post treatment

Results posted on

2021-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	755nm Alexandrite Laser With Lens Array 755nm Alexandrite laser with lens array
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	755nm Alexandrite Laser With Lens Array n=20 Participants 755nm Alexandrite laser with lens array
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	16 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	1 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score I	0 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score II	13 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score III	3 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score IV	4 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score V	0 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score VI	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 month post treatment

Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent. 3 subjects missed their visits.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser With Lens Array n=14 Participants 755nm Alexandrite laser with lens array
Severity Change in Acne Scarring	-2 score on a scale Standard Deviation 2.71

PRIMARY outcome

Timeframe: Baseline and 3 months post treatment

Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser With Lens Array n=17 Participants 755nm Alexandrite laser with lens array
Severity Change in Acne Scarring	-1 score on a scale Standard Deviation 3.15

SECONDARY outcome

Timeframe: 3 months post treatment

Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.

Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser With Lens Array n=17 Participants 755nm Alexandrite laser with lens array
Investigator Satisfaction Questionnaire Extremely Satisfied	0 participants
Investigator Satisfaction Questionnaire Satisfied	10 participants
Investigator Satisfaction Questionnaire Dissatisfied	7 participants
Investigator Satisfaction Questionnaire Extremely Dissatisfied	0 participants

SECONDARY outcome

Timeframe: 3 months post treatment

Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.

Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser With Lens Array n=17 Participants 755nm Alexandrite laser with lens array
Subject Satisfaction Questionnaire Extremely Satisfied	3 participants
Subject Satisfaction Questionnaire Satisfied	11 participants
Subject Satisfaction Questionnaire Dissatisfied	3 participants
Subject Satisfaction Questionnaire Extremely Dissatisfied	0 participants

Adverse Events

755nm Alexandrite Laser With Lens Array

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	755nm Alexandrite Laser With Lens Array n=20 participants at risk 755nm Alexandrite laser with lens array
Skin and subcutaneous tissue disorders Redness	85.0% 17/20 • Adverse Events occurring will be captured and followed throughout each subject's participation in the study, approximately 10 months.
Skin and subcutaneous tissue disorders Edema	55.0% 11/20 • Adverse Events occurring will be captured and followed throughout each subject's participation in the study, approximately 10 months.

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