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

Candela Corporation

Status: Active, not recruiting

Conditions: Pigmented Lesions; Wrinkle

Treatments: Device: PicoWay Laser System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04727099

PWY20001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Benign Pigmented Lesions

Experimental group

Description:

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

Treatment:

Device: PicoWay Laser System

Wrinkles

Experimental group

Description:

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

Treatment:

Device: PicoWay Laser System