Trial Outcomes & Findings for A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal (NCT NCT02635880)

Results Overview

Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Baseline and 6 weeks post-final treatment

Results posted on

2018-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Healty Evaluation of Clinical Study Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Group n=32 Participants The following types of benign pigmented lesions will be treated in this study: (1) lentigines (solar or senile); (2) ephelides (freckles); and (3) seborrheic keratosis.
Age, Categorical <=18 years	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants
Age, Categorical >=65 years	0 Participants n=32 Participants
Age, Continuous	46 years n=32 Participants
Sex: Female, Male Female	22 Participants n=32 Participants
Sex: Female, Male Male	10 Participants n=32 Participants
Region of Enrollment United States	32 Participants n=32 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks post-final treatment

Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement.

Outcome measures

Outcome measures
Measure	Investigational Enlighten Device n=32 Participants Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.
Percentage of Participants With Change of Treated Lesions Complete Improvement	44 % of participants
Percentage of Participants With Change of Treated Lesions Moderate Improvement	44 % of participants
Percentage of Participants With Change of Treated Lesions Mild Improvement	13 % of participants

SECONDARY outcome

Timeframe: 6 weeks post-final treatment

Degree of improvement in treated lesions at 6 weeks post-final treatment as assessed by the subject through a customized subject satisfaction survey. Survey was based upon a scoring 0 - Extremely Unsatisfied, 1 - Unsatisfied, 2 - Neutral, 3- Satisfied, 4 - Extremely Satisfied.

Outcome measures

Outcome measures
Measure	Investigational Enlighten Device n=32 Participants Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.
Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject Neutral	6 % of participants
Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject Satisfied	38 % of participants
Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject Extremely Satisified	56 % of participants

Adverse Events

Investigational Enlighten Device

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

Ginger Pocock

Cutera

Phone: 4156575702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place