PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

NCT ID: NCT03774849

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2020-11-12

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.

Conditions

Benign Pigmented Lesions; Facial Wrinkles

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Picoway™ 532nm fractional handpiece

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

Group Type: EXPERIMENTAL

PicoWay™ 730nm wavelength

Intervention Type: DEVICE

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

PicoWay™ 730nm wavelength

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

Group Type: EXPERIMENTAL

PicoWay™ 532nm fractional handpiece

Intervention Type: DEVICE

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

PicoWay ™1064nm fractional handpiece

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

Group Type: EXPERIMENTAL

PicoWay™ 1064nm fractional handpiece

Intervention Type: DEVICE

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

Interventions

PicoWay™ 532nm fractional handpiece

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

Intervention Type: DEVICE

PicoWay™ 730nm wavelength

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

Intervention Type: DEVICE

PicoWay™ 1064nm fractional handpiece

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Candela Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Lowery

Role: STUDY_DIRECTOR

Director of Clinical Affairs, Candela Corporation

Locations

Syneron Candela Institute for Excellence

Wayland, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PWY18010

Identifier Type: -

Identifier Source: org_study_id