Trial Outcomes & Findings for PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles (NCT NCT03774849)
NCT ID: NCT03774849
Last Updated: 2023-12-01
Results Overview
9-Point Fitzpatrick Wrinkle Scale (FWS) 1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis \[individual papules with yellow translucency under direct lighting\] and dyschromia) 7-9 Severe (multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
Baseline to 12-week follow-Up Visit
Results posted on
2023-12-01
Participant Flow
Participant milestones
| Measure |
Group A
Group A: Treatment of Benign Pigmented Lesions including dyschromia
|
Group B
Group B:Wrinkles including fine lines
|
Group A and B
Participants Enrolled in Both Group A and B
Treated for Benign Pigmented lesions and Wrinkles
|
|---|---|---|---|
|
Overall Study
STARTED
|
80
|
31
|
4
|
|
Overall Study
PicoWay 532nm
|
43
|
0
|
0
|
|
Overall Study
PicoWay 1064nm
|
1
|
31
|
0
|
|
Overall Study
PicoWay 730nm
|
22
|
0
|
0
|
|
Overall Study
PicoWay 532nm and 730nm
|
4
|
0
|
0
|
|
Overall Study
PicoWay 730nm and 1064nm
|
0
|
0
|
4
|
|
Overall Study
COMPLETED
|
70
|
31
|
4
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
Baseline characteristics by cohort
| Measure |
Group A
n=80 Participants
Group A: Benign Pigmented Lesions
Subjects will receive up to four study treatments with the PicoWay™ 532nm, 730nm, and/or 1064nm handpiece
|
Group B
n=31 Participants
Group B: Wrinkles
Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece
|
Group A and B
n=4 Participants
Group A and B: BPLs and Wrinkles
Subjects will receive up to four study treatments with the PicoWay™ 532nm, 730nm, and/or 1064nm handpiece
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 9 • n=5 Participants
|
56 years
STANDARD_DEVIATION 7 • n=7 Participants
|
62 years
STANDARD_DEVIATION 2 • n=5 Participants
|
52 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
31 participants
n=7 Participants
|
4 participants
n=5 Participants
|
115 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12-week follow-Up VisitPopulation: The blinded evaluation was not conducted for the assessment of primary endpoints at this time. Investigator assessment for wrinkle reduction was conducted via internal review of 'before and after' images to assess participants treated for wrinkles but using incorrect scale, so data for this group could not be analyzed accurately. If conducted in the future, the clinical study report will be addended.
9-Point Fitzpatrick Wrinkle Scale (FWS) 1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis \[individual papules with yellow translucency under direct lighting\] and dyschromia) 7-9 Severe (multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 12-week follow-Up VisitPopulation: The blinded evaluation was not conducted for the assessment of primary endpoints at this time. Investigator assessment for pigment reduction was conducted via internal review of 'before and after' images to assess participants treated for benign pigmented lesions but using incorrect scale, so data for this group could not be analyzed accurately. If conducted in the future, the clinical study report will be addended.
5-Point Pigment Clearance Score (Score, Clearance %, Description) 1. = 0-24% = Poor Response 2. = 25-49% = Fair Response 3. = 50-74% = Good Response 4. = 75-94% = Excellent Response 5. = \>95% = CompleteResponse
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-Treatment 2 at Week 6, Pre-Treatment 3 at Week 12, Pre-Treatment 4 at Week 18, 1 Month Follow-Up at Week 22, 2 Month Follow-Up at Week 26, and 3 Month Follow-Up at Week 30Population: Some subjects received treatments on multiple areas and reported different satisfaction scores with the different areas. Thus, the units analyzed reflect the individual areas treated and not the participant. Group A\&B (n=4) were double counted in this analysis because they were treated under both Group A and Group B. Group A (n=80) and Group B (n=31) is inclusive of Group A\&B (n=4) subjects.
During the 2nd Treatment Visit and all subsequent study visits (treatment and follow-up), Subject Satisfaction Surveys were obtained from all subjects. The scale used to evaluate subject satisfaction is a Likert-type rating Scale and follows -2, -1, 0, 1, 2 for responses of Extremely Dissatisfied, Somewhat Dissatisfied, Neither Satisfied nor Dissatisfied, Somewhat Satisfied and Extremely Satisfied respectfully. The scores are stratified according to treatment group.
Outcome measures
| Measure |
Group A
n=88 Treated areas
Group A: Benign Pigmented Lesions
Subjects will receive up to four study treatments with the PicoWay™ 532nm, 730nm, and/or 1064nm handpiece
|
Group B
n=35 Treated areas
Group B: Wrinkles
Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece
|
Group A and B
Group A and B: BPLs and Wrinkles
Subjects will receive up to four study treatments with the PicoWay™ 532nm, 730nm, and/or 1064nm handpiece
|
|---|---|---|---|
|
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
Pre-Treatment 2
|
0.85 score on a scale
Standard Deviation 0.96
|
0.65 score on a scale
Standard Deviation 0.85
|
—
|
|
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
Pre-Treatment 3
|
1.16 score on a scale
Standard Deviation 0.87
|
0.79 score on a scale
Standard Deviation 0.84
|
—
|
|
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
Pre-Treatment 4
|
1.19 score on a scale
Standard Deviation 0.88
|
0.91 score on a scale
Standard Deviation 1.06
|
—
|
|
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
1 Month Follow Up
|
1.13 score on a scale
Standard Deviation 1.02
|
0.71 score on a scale
Standard Deviation 1.24
|
—
|
|
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
2 Month Follow Up
|
1.25 score on a scale
Standard Deviation 1.07
|
0.72 score on a scale
Standard Deviation 1.05
|
—
|
|
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
3 Month Follow Up
|
1.38 score on a scale
Standard Deviation 0.81
|
0.56 score on a scale
Standard Deviation 1.19
|
—
|
Adverse Events
Group A: Benign Pigmented Lesions, 532nm
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group A: Benign Pigmented Lesions, 730nm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group A: Benign Pigmented Lesions, 1064nm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group A: Benign Pigmented Lesions, 532nm & 730nm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B: Wrinkles, 1064nm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group A and B: 730nm and 1064nm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Benign Pigmented Lesions, 532nm
n=43 participants at risk
Subjects will receive up to four study treatments
|
Group A: Benign Pigmented Lesions, 730nm
n=22 participants at risk
Subjects will receive up to four study treatments
|
Group A: Benign Pigmented Lesions, 1064nm
n=1 participants at risk
Subjects will receive up to four study treatments
|
Group A: Benign Pigmented Lesions, 532nm & 730nm
n=4 participants at risk
Subjects will receive up to four study treatments
|
Group B: Wrinkles, 1064nm
n=31 participants at risk
Subjects will receive up to four study treatments
|
Group A and B: 730nm and 1064nm
n=4 participants at risk
Subjects will receive up to four study treatments. BPLs treated at 730nm, wrinkles treated at 1064nm
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
13.6%
3/22 • Number of events 3 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/31 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
|
Skin and subcutaneous tissue disorders
Melasma activation
|
9.3%
4/43 • Number of events 4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/22 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/31 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
|
Skin and subcutaneous tissue disorders
herpetic outbreak
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
3.2%
1/31 • Number of events 1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
|
General disorders
unrelated symptoms
|
9.3%
4/43 • Number of events 4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/22 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/31 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
|
Skin and subcutaneous tissue disorders
Paradoxical Hypertrichosis
|
0.00%
0/43 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/22 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
3.2%
1/31 • Number of events 1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
|
Skin and subcutaneous tissue disorders
Cancer of nasal passage
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/22 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/31 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/22 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/1 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/31 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
0.00%
0/4 • Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place