PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

Candela Corporation

Status: Completed

Conditions: Benign Pigmented Lesions; Facial Wrinkles

Treatments: Device: PicoWay™ 730nm wavelength; Device: PicoWay™ 1064nm fractional handpiece; Device: PicoWay™ 532nm fractional handpiece

Study type: Interventional

Funder types: Industry

Identifiers

NCT03774849

PWY18010

Details and patient eligibility

About

Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.

Full description

Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength, PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy assessed by masked photographic evaluation. Optional biopsy collection for histological analysis of laser tissue effects.

Enrollment: 115 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Willing to provide signed informed consent
2. Adults age 21 to 80
3. Fitzpatrick Skin Type (FST) I to VI
4. Presence of benign pigmented Lesions assessed at baseline as Pigment Severity Score (PSS) of "2" or higher and/or wrinkles assessed at baseline as Fitzpatrick Wrinkle Score (FWS) of "2" or higher
5. Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study
6. Willing to abstain from any other procedures for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including surgery, light, laser, ultrasound or radiofrequency treatments
7. Willing to abstain from use of prescription cosmetic products for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including injections of neurotoxins or dermal fillers, skin lightening creams, and wrinkle creams
8. Willingness to adhere to study treatment and follow-up visit schedules

Exclusion Criteria

1. Pregnant, planning pregnancy or breast feeding
2. Allergy to topical or injectable lidocaine or similar medications
3. Allergy to topical steroid or similar medications
4. Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area
5. History of melanoma in the intended treatment area
6. History of keloid or hypertrophic scar formation
7. Use of topical or systemic retinoid therapy during the past six (6) months
8. Use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study
9. Use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study
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. Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months
14. The subject is not suitable, in the opinion of the clinician, for participation in the study due to medical or other reasons that could compromise the study integrity or subject safety

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 3 patient groups

Picoway™ 532nm fractional handpiece

Experimental group

Description:

Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece

Treatment:

Device: PicoWay™ 730nm wavelength

PicoWay™ 730nm wavelength

Experimental group

Description:

PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength.

Treatment:

Device: PicoWay™ 532nm fractional handpiece

PicoWay ™1064nm fractional handpiece

Experimental group

Description:

Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece

Treatment:

Device: PicoWay™ 1064nm fractional handpiece