Benign Pigmented Lesions, Facial Wrinkles
Conditions
Brief summary
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
Detailed description
Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength, PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy assessed by masked photographic evaluation. Optional biopsy collection for histological analysis of laser tissue effects.
Interventions
DEVICEPicoWay™ 532nm fractional handpiece
PicoWay™ Laser System is picosecond 532/1064/785 laser
DEVICEPicoWay™ 730nm wavelength
PicoWay™ Laser System is picosecond 532/1064/785 laser
DEVICEPicoWay™ 1064nm fractional handpiece
PicoWay™ Laser System is picosecond 532/1064/785 laser
Sponsors
Candela Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Willing to provide signed informed consent 2. Adults age 21 to 80 3. Fitzpatrick Skin Type (FST) I to VI 4. Presence of benign pigmented Lesions assessed at baseline as Pigment Severity Score (PSS) of 2 or higher and/or wrinkles assessed at baseline as Fitzpatrick Wrinkle Score (FWS) of 2 or higher 5. Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study 6. Willing to abstain from any other procedures for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including surgery, light, laser, ultrasound or radiofrequency treatments 7. Willing to abstain from use of prescription cosmetic products for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including injections of neurotoxins or dermal fillers, skin lightening creams, and wrinkle creams 8. Willingness to adhere to study treatment and follow-up visit schedules
Exclusion criteria
1. Pregnant, planning pregnancy or breast feeding 2. Allergy to topical or injectable lidocaine or similar medications 3. Allergy to topical steroid or similar medications 4. Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area 5. History of melanoma in the intended treatment area 6. History of keloid or hypertrophic scar formation 7. Use of topical or systemic retinoid therapy during the past six (6) months 8. Use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study 9. Use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study 10. Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment. 11. Open wound or infection in the intended treatment area 12. History of light induced seizure disorders 13. Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months 14. The subject is not suitable, in the opinion of the clinician, for participation in the study due to medical or other reasons that could compromise the study integrity or subject safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale | Baseline to 12-week follow-Up Visit | 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) |
| Change in Benign Pigmented Lesions From Baseline to 12 Weeks Post-study Treatment in Pigment Clearance Score (PCS) as Determined by Blinded Evaluators From Clinical Photography | Baseline to 12-week follow-Up Visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 30 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Group A: Benign Pigmented Lesions
Subjects will receive up to four study treatments with the PicoWay™ 532nm, 730nm, and/or 1064nm handpiece | 80 |
| Group B Group B: Wrinkles
Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece | 31 |
| 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 | 4 |
| Total | 115 |
Baseline characteristics
| Characteristic | Group A | Total | Group A and B | Group B |
|---|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 9 | 52 years STANDARD_DEVIATION 9 | 62 years STANDARD_DEVIATION 2 | 56 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 112 Participants | 4 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 58 Participants | 77 Participants | 1 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 6 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 32 Participants | 3 Participants | 11 Participants |
| Region of Enrollment United States | 80 participants | 115 participants | 4 participants | 31 participants |
| Sex: Female, Male Female | 73 Participants | 103 Participants | 4 Participants | 26 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 22 | 0 / 1 | 0 / 4 | 0 / 31 | 0 / 4 |
| other Total, other adverse events | 13 / 43 | 4 / 22 | 0 / 1 | 1 / 4 | 2 / 31 | 0 / 4 |
| serious Total, serious adverse events | 0 / 43 | 0 / 22 | 0 / 1 | 0 / 4 | 0 / 31 | 0 / 4 |
Outcome results
Primary
Change in Benign Pigmented Lesions From Baseline to 12 Weeks Post-study Treatment in Pigment Clearance Score (PCS) as Determined by Blinded Evaluators From Clinical Photography
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
Time frame: Baseline to 12-week follow-Up Visit
Population: 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.
Primary
Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale
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)
Time frame: Baseline to 12-week follow-Up Visit
Population: 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.
Secondary
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
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.
Time frame: 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 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | 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 |
| Group A | 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 |
| Group A | 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 |
| Group A | 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 |
| Group A | 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 |
| Group A | 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 |
| Group B | 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 | 0.72 score on a scale | Standard Deviation 1.05 |
| Group B | 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 | 0.65 score on a scale | Standard Deviation 0.85 |
| Group B | 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 | 0.71 score on a scale | Standard Deviation 1.24 |
| Group B | 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 | 0.79 score on a scale | Standard Deviation 0.84 |
| Group B | 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 | 0.56 score on a scale | Standard Deviation 1.19 |
| Group B | 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 | 0.91 score on a scale | Standard Deviation 1.06 |