Trial Outcomes & Findings for A Single-Center 2-Arm Study for Lentigines on the Hands (NCT NCT02763072)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

4 weeks post-final treatment

Results posted on

2023-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Excel V Laser 12 subjects will be enrolled in the Excel V group, .	Enlighten Laser 12 subjects will be enrolled in the Enligthen group
Overall Study STARTED	12	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	1	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	Excel V Laser n=12 Participants 12 subjects will be enrolled in the Excel V group	Enlighten Laser n=12 Participants 12 subjects will be enrolled in the Enlighten group	Total n=24 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 9.0 • n=12 Participants	64.8 years STANDARD_DEVIATION 8.6 • n=12 Participants	63.3 years STANDARD_DEVIATION 8.7 • n=24 Participants
Sex: Female, Male Female	12 Participants n=12 Participants	12 Participants n=12 Participants	24 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	12 participants n=12 Participants	24 participants n=24 Participants

PRIMARY outcome

Timeframe: 4 weeks post-final treatment

Population: Study terminated prior to outcome data collected due to company change in priorities.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks post final treatment

Population: 1 subject was lost to follow up in the Excel V group

Degree of improvement in the overall appearance of the hands as assessed by blinded reviewers using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change Higher scores indicate better outcomes

Outcome measures

Outcome measures
Measure	Enlighten Laser n=12 Participants 12 subjects will receive treatment with the Enlighten laser.	Excel V Laser n=11 Participants 12 subjects will receive treatment with the Excel V laser.
Physician's Global Assessment Score of the Overall Appearance of the Hands	3.8 score on a scale Standard Deviation 0.6	3.9 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 4 weeks post final treatment

Population: 1 subject was lost to follow up in the Excel V group

Degree of improvement in the Skin Texture of the hands as assessed using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change. Higher scores indicate better outcomes

Outcome measures

Outcome measures
Measure	Enlighten Laser n=12 Participants 12 subjects will receive treatment with the Enlighten laser.	Excel V Laser n=11 Participants 12 subjects will receive treatment with the Excel V laser.
Physician's Global Assessment Score of Skin Texture of the Hands	2.9 score on a scale Standard Deviation 1.8	3.1 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 4 weeks post final treatment

Population: 1 subject was lost to follow up in the Excel V group

Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome

Outcome measures

Outcome measures
Measure	Enlighten Laser n=12 Participants 12 subjects will receive treatment with the Enlighten laser.	Excel V Laser n=11 Participants 12 subjects will receive treatment with the Excel V laser.
Subject Satisfaction Very Satisfied	9 Participants	8 Participants
Subject Satisfaction Satisfied	2 Participants	3 Participants
Subject Satisfaction Neutral	1 Participants	0 Participants

Adverse Events

Excel V Laser

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Enlighten Laser

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Excel V Laser n=12 participants at risk 12 subjects will be enrolled in the Excel V group	Enlighten Laser n=12 participants at risk 12 subjects will be enrolled in the Enlighten group.
Skin and subcutaneous tissue disorders Erythema	50.0% 6/12 • 4 weeks post final treatment, up to 17 weeks	75.0% 9/12 • 4 weeks post final treatment, up to 17 weeks
Skin and subcutaneous tissue disorders Darkening of vessel	0.00% 0/12 • 4 weeks post final treatment, up to 17 weeks	41.7% 5/12 • 4 weeks post final treatment, up to 17 weeks
Skin and subcutaneous tissue disorders Hyperpigmentation	25.0% 3/12 • 4 weeks post final treatment, up to 17 weeks	25.0% 3/12 • 4 weeks post final treatment, up to 17 weeks

Additional Information

Margot Doucette

Cutera

Phone: 415-656-9612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place