N/A
N=115
PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
Benign Pigmented Lesions · Facial Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT03774849 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PicoWay™ 532nm fractional handpiece (Device); PicoWay™ 730nm wavelength (Device); PicoWay™ 1064nm fractional handpiece (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Candela Corporation
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale |
— | — |
| PRIMARY 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 |
— | — |
| SECONDARY 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 |
0.85; 0.65; 1.16; 0.79; 1.19; 0.91 | — |
Summary
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
Eligibility Criteria
Inclusion Criteria
- Willing to provide signed informed consent
- Adults age 21 to 80
- Fitzpatrick Skin Type (FST) I to VI
- 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
- Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study
- 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
- 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
- Willingness to adhere to study treatment and follow-up visit schedules
Exclusion Criteria
- Pregnant, planning pregnancy or breast feeding
- Allergy to topical or injectable lidocaine or similar medications
- Allergy to topical steroid or similar medications
- Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area
- History of melanoma in the intended treatment area
- History of keloid or hypertrophic scar formation
- Use of topical or systemic retinoid therapy during the past six (6) months
- Use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study
- Use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study
- 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
- Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months
- 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
Data sourced from ClinicalTrials.gov (NCT03774849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.