Trial Outcomes & Findings for Laser Removal of Age (Sun) Spots on Hands (NCT NCT01885871)

Last Updated: 2018-02-27

Results Overview

Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

12 weeks post- final treatment

Results posted on

2018-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laser Removal of Age (Sun) Spots on Hands

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser n=20 Participants Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Age, Continuous	52 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post- final treatment

Population: Based on blinded photographic assessments of 20 subjects. Scores \>/=1 indicate clearing.

Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.

Outcome measures

Outcome measures
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser n=20 Participants Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Median VAS Improvement Score as Assessed by Blinded Physician Reviewers	1.5 units on a scale Interval 1.25 to 2.0

SECONDARY outcome

Timeframe: 12 weeks post- final treatment

Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores \>/=1 indicate improvement.

Outcome measures

Outcome measures
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser n=20 Participants Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Percent of Participants With Improvement Score >/=1	90 percent of participants

SECONDARY outcome

Timeframe: 12 weeks post- final treatment

Population: Based on subject questionnaires, 90% of subjects reported improvement (clearing) in benign pigmented lesions at 12 weeks post- final treatment. Scores \> or =1 indicate improvement.

Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change.

Outcome measures

Outcome measures
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser n=20 Participants Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines	95 percent of participants

SECONDARY outcome

Timeframe: During treatments

Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments.

Outcome measures

Outcome measures
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser n=20 Participants Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Mean Pain Score Associated With Laser Treatments	2.0 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: During study duration 0-6 months.

Outcome measures

Outcome measures
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser n=20 Participants Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Percent of Subjects With Post-treatment Adverse Event Erythema (redness)	100 percent of participants
Percent of Subjects With Post-treatment Adverse Event Edema (swelling)	100 percent of participants
Percent of Subjects With Post-treatment Adverse Event Crusting (scabbing)	100 percent of participants
Percent of Subjects With Post-treatment Adverse Event Purpura (bruising)	65 percent of participants
Percent of Subjects With Post-treatment Adverse Event Blisters	15 percent of participants
Percent of Subjects With Post-treatment Adverse Event Eczema	5 percent of participants

Adverse Events

Picosecond Q-Switched Nd:YAG 1064/532 nm Laser

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser n=20 participants at risk Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
Skin and subcutaneous tissue disorders Edema (swelling)	100.0% 20/20 • Number of events 20 • Adverse Event Data was collected immediately post treatment, 3 days and 14 days after treatment as well as 6, 12, and 24 weeks.
Skin and subcutaneous tissue disorders Erythema (Redness)	100.0% 20/20 • Number of events 20 • Adverse Event Data was collected immediately post treatment, 3 days and 14 days after treatment as well as 6, 12, and 24 weeks.
Skin and subcutaneous tissue disorders Purpura (Bruising)	65.0% 13/20 • Number of events 13 • Adverse Event Data was collected immediately post treatment, 3 days and 14 days after treatment as well as 6, 12, and 24 weeks.
Skin and subcutaneous tissue disorders Blisters	15.0% 3/20 • Number of events 3 • Adverse Event Data was collected immediately post treatment, 3 days and 14 days after treatment as well as 6, 12, and 24 weeks.
Skin and subcutaneous tissue disorders Eczema	5.0% 1/20 • Number of events 1 • Adverse Event Data was collected immediately post treatment, 3 days and 14 days after treatment as well as 6, 12, and 24 weeks.

Additional Information

Clinical Research Department

Cutera, Inc

Phone: 1-888-428-8372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place