Clinical trial NCT03774849: PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
Official title: Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Pigmented Lesions
Facial Wrinkles
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale
timeFrame: Baseline to 12-week follow-Up Visit
measure: Change in Benign Pigmented Lesions From Baseline to 12 Weeks Post-study Treatment in Pigment Clearance Score (PCS) as Determined by Blinded Evaluators From Clinical Photography
timeFrame: Baseline to 12-week follow-Up Visit
Secondary outcomes:
measure: Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
timeFrame: Pre-Treatment 2 at Week 6, Pre-Treatment 3 at Week 12, Pre-Treatment 4 at Week 18, 1 Month Follow-Up at Week 22, 2 Month Follow-Up at Week 26, and 3 Month Follow-Up at Week 30
Other outcomes:
Locations:
city: Wayland
country: United States
facility: Syneron Candela Institute for Excellence
state: Massachusetts
Study officials:
affiliation: Director of Clinical Affairs, Candela Corporation
name: Joseph Lowery
role: STUDY_DIRECTOR
References: