PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

NCT03774849 | Completed Results FDA Device

• 1 other identifier: PWY18010
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Pigmented Lesions; Facial Wrinkles

Outcome Measures

Primary Outcomes (2)

• 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) 1. = 0-24% = Poor Response 2. = 25-49% = Fair Response 3. = 50-74% = Good Response 4. = 75-94% = Excellent Response 5. = \>95% = CompleteResponse

  Baseline to 12-week follow-Up Visit

Secondary Outcomes (1)

• 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

Study Arms (3)

Picoway™ 532nm fractional handpiece

EXPERIMENTAL

Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece

Device: PicoWay™ 730nm wavelength

PicoWay™ 730nm wavelength

EXPERIMENTAL

PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength.

Device: PicoWay™ 532nm fractional handpiece

PicoWay ™1064nm fractional handpiece

EXPERIMENTAL

Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece

Device: PicoWay™ 1064nm fractional handpiece

Interventions

PicoWay™ 532nm fractional handpiece DEVICE

PicoWay™ Laser System is picosecond 532/1064/785 laser

PicoWay™ 730nm wavelength

PicoWay™ 730nm wavelength DEVICE

PicoWay™ Laser System is picosecond 532/1064/785 laser

Picoway™ 532nm fractional handpiece

PicoWay™ 1064nm fractional handpiece DEVICE

PicoWay™ Laser System is picosecond 532/1064/785 laser

PicoWay ™1064nm fractional handpiece

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide signed informed consent
• Adults age 21 to 80
• Fitzpatrick Skin Type (FST) I to VI
• 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
• Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study
• 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
• 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
• Willingness to adhere to study treatment and follow-up visit schedules

You may not qualify if:

• Pregnant, planning pregnancy or breast feeding
• Allergy to topical or injectable lidocaine or similar medications
• Allergy to topical steroid or similar medications
• Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area
• History of melanoma in the intended treatment area
• History of keloid or hypertrophic scar formation
• Use of topical or systemic retinoid therapy during the past six (6) months
• Use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study
• Use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study
• Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment.
• Open wound or infection in the intended treatment area
• History of light induced seizure disorders
• Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months
• 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

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (1)

Syneron Candela Institute for Excellence

Wayland, Massachusetts, 01778, United States

Location

Results Point of Contact

• Title: Dr. Konika Patel Schallen
• Organization: Candela

cie.studyinfo@candelamedical.com

5083580357

Study Officials

• Joseph Lowery

  Director of Clinical Affairs, Candela Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: December 5, 2018
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)