Trial Outcomes & Findings for Study for the RevLite Laser System for Facial Solar Lentigines (NCT NCT02110108)

NCT ID: NCT02110108

Last Updated: 2021-11-30

Results Overview

Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 1 month post last treatment
• Results posted on: 2021-11-30

Participant Flow

Participant milestones

Measure	Revlite Laser System Revlite Laser System Revlite Laser System: Revlite Laser System with ½ of the face treated with the 1064nm wavelength and the other half of the face treated with combination of both the 1064nm and 532nm wavelengths.
Overall Study STARTED	10
Overall Study RevLite Single Wavelength	10
Overall Study RevLite Combo Wavelength	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study for the RevLite Laser System for Facial Solar Lentigines

Baseline characteristics by cohort

Measure	Revlite Laser System n=10 Participants Revlite Laser System Revlite Laser System: Revlite Laser System for the Treatment of Facial Solar Lentigines
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	8 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	2 Participants n=93 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type I	1 Participants n=93 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type II	7 Participants n=93 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type III	2 Participants n=93 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type IV	0 Participants n=93 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type V	0 Participants n=93 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type VI	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month post last treatment

Population: Since all subjects who enrolled received at least 1 treatment and had a 30 day follow up to this treatment, all subject information is included. The time frame is based off of the follow up to each subject's final treatment.

Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.

Outcome measures

Measure	Revlite Laser System Single n=10 Participants Revlite Laser System using just 1064 nm wavelength	Revlite Laser System- Combo n=10 Participants Revlite Laser System using 1064 nm and 532 nm wavelengths
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale Very Much Improved	0 Participants	1 Participants
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale Much Improved	3 Participants	3 Participants
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale Improved	6 Participants	4 Participants
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale No Change	1 Participants	2 Participants
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale Worse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month post last treatment

Population: Since all subjects who enrolled received at least 1 treatment and had a 30 day follow up to this treatment, all subject information is included. The time frame is based off of the follow up to each subject's final treatment.

The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1).

Outcome measures

Measure	Revlite Laser System Single n=10 Participants Revlite Laser System using just 1064 nm wavelength	Revlite Laser System- Combo n=10 Participants Revlite Laser System using 1064 nm and 532 nm wavelengths
Physician Satisfaction Questionnaire	3.70 score on a scale Standard Deviation 1.63	3.600 score on a scale Standard Deviation 1.65

Adverse Events

Revlite Laser System Single

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Revlite Laser System Combo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Revlite Laser System Single n=10 participants at risk Revlite Laser System Revlite Laser System 1064nm wavelength	Revlite Laser System Combo n=10 participants at risk Revlite Laser System Revlite Laser System: Combination of both the 1064nm and 532nm wavelengths
Nervous system disorders Pain	50.0% 5/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.	50.0% 5/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.
Skin and subcutaneous tissue disorders Redness	90.0% 9/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.	90.0% 9/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.
Skin and subcutaneous tissue disorders Swelling	50.0% 5/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.	30.0% 3/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.
Skin and subcutaneous tissue disorders Crusting	40.0% 4/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.	40.0% 4/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.
Skin and subcutaneous tissue disorders Hypopigmentation	10.0% 1/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.	0.00% 0/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.
Skin and subcutaneous tissue disorders Acne	10.0% 1/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 months.	10.0% 1/10 • Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 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