Trial Outcomes & Findings for The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars (NCT NCT02103816)

Last Updated: 2020-12-17

Results Overview

This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

3 months post treatment

Results posted on

2020-12-17

Participant Flow

One additional patient was enrolled beyond the limitations specified by the original protocol. The protocol was amended (and approved by the IRB) part way through the study to allow for the enrollment of this additional subject.

Participant milestones

Participant milestones
Measure	SmartLipo Triplex Laser System Along With the SideLaze800 Hand SmartLipo Triplex laser system along with the SideLaze800 hand piece
Overall Study STARTED	21
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SmartLipo Triplex Laser System Along With the SideLaze800 Hand n=21 Participants SmartLipo Triplex laser system along with the SideLaze800 hand piece
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	4 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score I	0 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score II	0 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score III	11 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score IV	7 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score V	3 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Score VI	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post treatment

Population: 1 subject completed the follow up over the phone, so there is no physician score for this subject. 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up.

Outcome measures

Outcome measures
Measure	SmartLipo Triplex Laser System Along With the SideLaze800 Hand n=14 Participants SmartLipo Triplex laser system along with the SideLaze800 hand piece
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale Very Much Improved	28.6 percentage of participants
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale Much Improved	57.1 percentage of participants
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale Improved	14.3 percentage of participants

SECONDARY outcome

Timeframe: 3 months post treatment

The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.

Outcome measures

Outcome measures
Measure	SmartLipo Triplex Laser System Along With the SideLaze800 Hand n=14 Participants SmartLipo Triplex laser system along with the SideLaze800 hand piece
Investigator Satisfaction Questionnaire Extremely Satisfied	6 Participants
Investigator Satisfaction Questionnaire Satisfied	5 Participants
Investigator Satisfaction Questionnaire Slightly Satisfied	3 Participants

SECONDARY outcome

Timeframe: 3 months post treatment

Population: 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up.

The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.

Outcome measures

Outcome measures
Measure	SmartLipo Triplex Laser System Along With the SideLaze800 Hand n=15 Participants SmartLipo Triplex laser system along with the SideLaze800 hand piece
Subject Satisfaction Questionnaire Extremely Satisfied	6 Participants
Subject Satisfaction Questionnaire Satisfied	6 Participants
Subject Satisfaction Questionnaire Slightly Satisfied	2 Participants
Subject Satisfaction Questionnaire slightly dissatisfied	1 Participants

Adverse Events

SmartLipo Triplex Laser System Along With the SideLaze800 Hand

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SmartLipo Triplex Laser System Along With the SideLaze800 Hand n=21 participants at risk SmartLipo Triplex laser system along with the SideLaze800 hand piece
Nervous system disorders Pain	9.5% 2/21 • Adverse Events occurring were captured and followed for the study duration, about 5 months.
Skin and subcutaneous tissue disorders Swelling	71.4% 15/21 • Adverse Events occurring were captured and followed for the study duration, about 5 months.
Skin and subcutaneous tissue disorders Bruising	14.3% 3/21 • Adverse Events occurring were captured and followed for the study duration, about 5 months.
Nervous system disorders Numbness	28.6% 6/21 • Adverse Events occurring were captured and followed for the study duration, about 5 months.
Nervous system disorders Headache	4.8% 1/21 • Adverse Events occurring were captured and followed for the study duration, about 5 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