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

NCT04727099 | Unknown FDA Device

• 1 other identifier: PWY20001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkle; Pigmented Lesions

Outcome Measures

Primary Outcomes (4)

• Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)

  Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."

  12 months

• Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS)

  Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Pigment Improvement Score (PIS) where a score of 0 = "no improvement" and a score of 4 = "Excellent response: Most or all lesions much lighter or gone"

  12 months

• Wrinkles and Global Aesthetic Improvement Score (GAIS) 3 month follow up

  Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."

  12 months

• Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up

  Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale where a score of 1 = "fine wrinkles or mild elastosis" and 9 = "deep wrinkles or severe elastosis".

  12 months

Secondary Outcomes (5)

• BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up

  10 months

• BPLs and PIS 3 month follow up

  10 months

• Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 1 month follow up

  10 months

• Wrinkles and Global Aesthetic Improvement Score (GAIS) 1 month follow up

  10 months

• Overall Subject Satisfaction 3 month follow up

  12 months

Other Outcomes (1)

• Evaluation Adverse Events

  through study completion, approximately 12 months

Study Arms (2)

Benign Pigmented Lesions

EXPERIMENTAL

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

Device: PicoWay Laser System

Wrinkles

EXPERIMENTAL

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

Device: PicoWay Laser System

Interventions

PicoWay Laser System 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.

Benign Pigmented Lesions; Wrinkles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age or older
• Willingness to provide signed, informed consent to participate in the study
• Presence of mild or greater benign pigmented lesions, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) \>/= 1.
• Willingness to adhere to study treatment and follow-up schedule
• Willingness to adhere to post-treatment care instructions
• Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
• 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

You may not qualify if:

• Pregnant, planning pregnancy during the study, or breast feeding
• Tattooed skin in the intended treatment area unless tattoo removal treatment is to be performed.
• Active sun tan in the intended treatment area
• History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
• History of melanoma
• History of vitiligo in the intended treatment area
• History of keloid or hypertrophic scar formation
• History of Melasma in the intended treatment area per Investigator's discretion
• Use of systemic retinoid therapy (e.g. Accutane) during the past 6 months
• 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
• 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
• 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

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (1)

Candela Institute of Excellence

Marlborough, Massachusetts, 01752, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: January 27, 2021
• Study Start: September 28, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)