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

Not Applicable

Active, not recruiting

• Conditions: Pigmented Lesions; Wrinkle
• Interventions: Device: PicoWay Laser System

• Registration Number: NCT04727099
• Lead Sponsor: Candela Corporation

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).

Study Timeline

• Study Start: 2020-09-28
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wrinkles	PicoWay Laser System	Up to six (6) treatments with PicoWay laser for treatment of wrinkles
Benign Pigmented Lesions	PicoWay Laser System	Up to six (6) treatments with PicoWay laser for treatment of benign pigmented lesions

Primary Outcome Measures

Name	Time	Method
Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)	12 months	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."
Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS)	12 months	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"
Wrinkles and Global Aesthetic Improvement Score (GAIS) 3 month follow up	12 months	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."
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up	12 months	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".

Secondary Outcome Measures

Name	Time	Method
BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up	10 months	Improvement in BPLs from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
BPLs and PIS 3 month follow up	10 months	Improvement in BPLs from Baseline to 1 Month follow-up (= 10 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"
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 1 month follow up	10 months	Improvement in the appearance of wrinkles from Baseline to 1 Month follow-up (= 10 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".
Wrinkles and Global Aesthetic Improvement Score (GAIS) 1 month follow up	10 months	Improvement in the appearance of wrinkles from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
Overall Subject Satisfaction 3 month follow up	12 months	Overall subject satisfaction with study treatments per treatment indication as measured by Subject Satisfaction Scale and Subject Global Aesthetic Improvement Score (SGAIS). (Baseline to 3 month follow up, approximately 12 months)

Trial Locations

Locations (1)

Candela Institute of Excellence; 🇺🇸 Marlborough, Massachusetts, United States