Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™

NCT ID: NCT04727099

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2023-12-31

Brief Summary

This study is intended to demonstrate the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.

Detailed Description

This is a prospective, non-randomized, open-label study evaluating the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.

Up to 200 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to 6 treatments to the face and/or off-face locations with treatment intervals of 4 weeks +/- 2 weeks. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment. Total study duration is approximately 12 months (up to 9 months for treatment and 3 months for follow up).

Conditions

Wrinkle; Pigmented Lesions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Benign Pigmented Lesions

Up to six (6) treatments with PicoWay laser for treatment of benign pigmented lesions

Group Type: EXPERIMENTAL

PicoWay Laser System

Intervention Type: DEVICE

The PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles.

Wrinkles

Up to six (6) treatments with PicoWay laser for treatment of wrinkles

Group Type: EXPERIMENTAL

PicoWay Laser System

Intervention Type: DEVICE

The PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles.

Interventions

PicoWay Laser System

The PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. At least 18 years of age or older

2. Willingness to provide signed, informed consent to participate in the study

3. Presence of mild or greater benign pigmented lesions, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1.

4. Willingness to adhere to study treatment and follow-up schedule

5. Willingness to adhere to post-treatment care instructions

6. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes

7. Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study

Exclusion Criteria

1. Pregnant, planning pregnancy during the study, or breast feeding

2. Tattooed skin in the intended treatment area unless tattoo removal treatment is to be performed.

3. Active sun tan in the intended treatment area

4. History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication

5. History of melanoma

6. History of vitiligo in the intended treatment area

7. History of keloid or hypertrophic scar formation

8. History of Melasma in the intended treatment area per Investigator's discretion

9. Use of systemic retinoid therapy (e.g. Accutane) during the past 6 months

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. The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety

14. Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Candela Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Candela Institute of Excellence

Marlborough, Massachusetts, United States

Countries

United States

Other Identifiers

PWY20001

Identifier Type: -

Identifier Source: org_study_id