Clinical trial NCT04727099: Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
Official title: Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wrinkle
Pigmented Lesions
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)
timeFrame: 12 months
measure: Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS)
timeFrame: 12 months
measure: Wrinkles and Global Aesthetic Improvement Score (GAIS) 3 month follow up
timeFrame: 12 months
measure: Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up
timeFrame: 12 months
Secondary outcomes:
measure: BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up
timeFrame: 10 months
measure: BPLs and PIS 3 month follow up
timeFrame: 10 months
measure: Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 1 month follow up
timeFrame: 10 months
measure: Wrinkles and Global Aesthetic Improvement Score (GAIS) 1 month follow up
timeFrame: 10 months
measure: Overall Subject Satisfaction 3 month follow up
timeFrame: 12 months
Other outcomes:
measure: Evaluation Adverse Events
timeFrame: through study completion, approximately 12 months
Locations:
city: Marlborough
country: United States
facility: Candela Institute of Excellence
state: Massachusetts
Study officials:
References: