Trial Outcomes & Findings for Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte (NCT NCT01491620)

Results Overview

Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

24 weeks

Results posted on

2022-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	532 nm KTP Laser Treatment 532 nm KTP laser: Laser treatment sessions to neck and/or chest.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	532 nm KTP Laser Treatment n=24 Participants 532 nm KTP laser: Two laser treatment sessions to neck and/or chest. 6 weeks apart.
Age, Continuous	52.5 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area

Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values

Outcome measures

Outcome measures
Measure	532 nm KTP Laser Treatment n=17 Participants 532 nm KTP laser: Laser treatment sessions to neck and/or chest.
Severity Assessment Score Neck	-0.06 score on a scale Standard Deviation 0.66
Severity Assessment Score Upper Chest	0.2 score on a scale Standard Deviation 0.45

PRIMARY outcome

Timeframe: 24 weeks

Population: Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area

Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale. Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome

Outcome measures

Outcome measures
Measure	532 nm KTP Laser Treatment n=17 Participants 532 nm KTP laser: Laser treatment sessions to neck and/or chest.
Physician's Global Assessment (Blinded) Neck Area	.06 score on a scale Standard Deviation .97
Physician's Global Assessment (Blinded) Upper Chest Area	1 score on a scale Standard Deviation .71

Adverse Events

532 nm KTP Laser Treatment

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	532 nm KTP Laser Treatment n=24 participants at risk 532 nm KTP laser: Laser treatment sessions to neck or chest
Skin and subcutaneous tissue disorders Erythema	100.0% 24/24

Additional Information

Margot Doucette

Cutera

Phone: 415-657-5518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place