Trial Outcomes & Findings for Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment (NCT NCT05027282)

Last Updated: 2023-11-22

Results Overview

Improvement in the appearance of at least one measurement of photoaging damage (fine wrinkles, skin texture, dyschromia/pigment, skin radiance, pore size or overall appearance), each assessed by the investigator using the quartile improvement score comparing standard 2D baseline photograph captured via Canfield VISIA CA system. The Quartile Improvement Score ranges from 0 to 4, with 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, and 4 = 76% to 100% improvement. Higher scores indicated greater improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

3 months post treatment, up to 7 months

Results posted on

2023-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces n=28 Participants CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Age, Continuous	39.9 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post treatment, up to 7 months

Population: Participants with 3 months of follow up were included

Outcome measures

Outcome measures
Measure	CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces n=26 Participants CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Mean Improvement in Photoaging Damage Appearance at 3 Months Post Treatment	2.81 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 1 month post treatment, up to 5 months

Population: Participants with 1 month of follow up were included.

Outcome measures

Outcome measures
Measure	CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces n=27 Participants CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.: CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Mean Improvement in Photoaging Damage Appearance at 1 Month Post Treatment	2.59 units on a scale Standard Deviation 0.8

Adverse Events

CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm Handpieces

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Bausch Health Americas, Inc

Phone: 19083009920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor for details.
Publication restrictions are in place

Restriction type: OTHER