Status:
COMPLETED
PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
Lead Sponsor:
Candela Corporation
Conditions:
Benign Pigmented Lesions
Facial Wrinkles
Eligibility:
All Genders
21-80 years
Phase:
NA
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 pigmen...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2020
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03774849
Start Date
December 5 2018
End Date
November 12 2020
Last Update
December 1 2023
Active Locations (1)
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1
Syneron Candela Institute for Excellence
Wayland, Massachusetts, United States, 01778