PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

Facial Wrinkles Clinical Trial

Official title:

Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774849
• Other study ID #: PWY18010
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: November 12, 2020

Study information

• Verified date: November 2023
• Source: Candela Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Pigmented Lesions
• Facial Wrinkles

Intervention

Device:
• PicoWay™ 532nm fractional handpiece
PicoWay™ Laser System is picosecond 532/1064/785 laser
• PicoWay™ 730nm wavelength
PicoWay™ Laser System is picosecond 532/1064/785 laser
• PicoWay™ 1064nm fractional handpiece
PicoWay™ Laser System is picosecond 532/1064/785 laser

Locations

Country	Name	City	State
United States	Syneron Candela Institute for Excellence	Wayland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Candela Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Baseline to 12-week follow-Up Visit
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); = 0-24% = Poor Response; = 25-49% = Fair Response; = 50-74% = Good Response; = 75-94% = Excellent Response; = >95% = CompleteResponse	Baseline to 12-week follow-Up Visit
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.	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