Trial Outcomes & Findings for Laser Treatment for Fresh Surgical Scars and Mature Scars (NCT NCT01030198)

Last Updated: 2020-12-17

Results Overview

The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Fresh Surgical Scars Device: RevLite (Laser Treatment)	Mature Scars Device: RevLite (Laser Treatment)
Overall Study STARTED	0	7
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Fresh Surgical Scars Device: RevLite (Laser Treatment)	Mature Scars Device: RevLite (Laser Treatment)
Overall Study Could not measure efficacy accurately	0	7

Baseline Characteristics

Laser Treatment for Fresh Surgical Scars and Mature Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fresh Surgical Scars Treatment of scars Device: Revlite	Mature Scars n=7 Participants Treatment of scars Device: Revlite	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	—	7 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical >=65 years	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	—	48.4 years STANDARD_DEVIATION 10.2 • n=4 Participants	48.4 years STANDARD_DEVIATION 10.2 • n=27 Participants
Sex: Female, Male Female	—	7 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	—	7 participants n=4 Participants	7 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)

Population: Could not measure accurately with measurement tools.

The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.

Outcome measures

Outcome data not reported

Adverse Events

Fresh Surgical Scars

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mature Scars

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

Jamie Trimper

Cynosure, Inc.

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