CompletedNot Applicable

PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

United States115 participantsStarted 2018-12-05

Plain-language summary

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

Who can participate

Age range21 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Trial details

NCT IDNCT03774849

SponsorCandela Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-12

Results submitted2023-03-17

View on ClinicalTrials.gov More Benign Pigmented Lesions trials

Who can participate

Age range21 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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