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Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picoway™ 532nm fractional handpiece | Experimental | Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece |
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| PicoWay™ 730nm wavelength | Experimental | PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength. |
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| PicoWay ™1064nm fractional handpiece | Experimental | Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PicoWay™ 532nm fractional handpiece | Device | PicoWay™ Laser System is picosecond 532/1064/785 laser |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 12-week follow-Up Visit |
| 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)
| Baseline to 12-week follow-Up Visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Lowery | Director of Clinical Affairs, Candela Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneron Candela Institute for Excellence | Wayland | Massachusetts | 01778 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Group A: Treatment of Benign Pigmented Lesions including dyschromia |
| FG001 | Group B | Group B:Wrinkles including fine lines |
| FG002 | Group A and B | Participants Enrolled in Both Group A and B Treated for Benign Pigmented lesions and Wrinkles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Group A: Benign Pigmented Lesions Subjects will receive up to four study treatments with the PicoWay™ 532nm, 730nm, and/or 1064nm handpiece |
| BG001 | Group B | Group B: Wrinkles Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Baseline to 12-week follow-Up Visit |
|
Adverse event data was collected from baseline through study completion, approximately 30 weeks
Candela Picoway laser system is a non-significant risk device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Benign Pigmented Lesions, 532nm | Subjects will receive up to four study treatments |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Konika Patel Schallen | Candela | 5083580357 | cie.studyinfo@candelamedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2018 | Jul 13, 2023 | Prot_SAP_002.pdf |
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| PicoWay™ 730nm wavelength | Device | PicoWay™ Laser System is picosecond 532/1064/785 laser |
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| PicoWay™ 1064nm fractional handpiece | Device | PicoWay™ Laser System is picosecond 532/1064/785 laser |
|
| 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Group A |
Group A: Benign Pigmented Lesions Subjects will receive up to four study treatments with the PicoWay™ 532nm, 730nm, and/or 1064nm handpiece |
| OG001 | Group B | Group B: Wrinkles Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece |
| OG002 | 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 |
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a 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 | Treated areas | Treated areas |
|
|
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| 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)
| 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. | Posted | Baseline to 12-week follow-Up Visit |
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 13 |
| 43 |
| EG001 | Group A: Benign Pigmented Lesions, 730nm | Subjects will receive up to four study treatments | 0 | 22 | 0 | 22 | 4 | 22 |
| EG002 | Group A: Benign Pigmented Lesions, 1064nm | Subjects will receive up to four study treatments | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Group A: Benign Pigmented Lesions, 532nm & 730nm | Subjects will receive up to four study treatments | 0 | 4 | 0 | 4 | 1 | 4 |
| EG004 | Group B: Wrinkles, 1064nm | Subjects will receive up to four study treatments | 0 | 31 | 0 | 31 | 2 | 31 |
| EG005 | Group A and B: 730nm and 1064nm | Subjects will receive up to four study treatments. BPLs treated at 730nm, wrinkles treated at 1064nm | 0 | 4 | 0 | 4 | 0 | 4 |
| Melasma activation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| herpetic outbreak | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| unrelated symptoms | General disorders | Non-systematic Assessment | headache, dizziness, aches, feeling feverish |
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| Paradoxical Hypertrichosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Cancer of nasal passage | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pre-Treatment 4 |
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| 1 Month Follow Up |
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| 2 Month Follow Up |
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| 3 Month Follow Up |
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