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Completed

NCT Number: NCT03774849

PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

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

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Key information

Conditions

Benign Pigmented Lesions Facial Wrinkles

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syneron Candela Institute for Excellence

Wayland, Massachusetts, 01778, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PicoWay™ 532nm fractional handpiece

Device

PicoWay™ Laser System is picosecond 532/1064/785 laser

PicoWay™ 730nm wavelength

Device

PicoWay™ Laser System is picosecond 532/1064/785 laser

PicoWay™ 1064nm fractional handpiece

Device

PicoWay™ Laser System is picosecond 532/1064/785 laser

Primary outcomes

  1. Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale

    Time frame: Baseline to 12-week follow-Up Visit

    9-Point Fitzpatrick Wrinkle Scale (FWS)

    1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia) 7-9 Severe (multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis)

  2. 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

    Time frame: Baseline to 12-week follow-Up Visit

    5-Point Pigment Clearance Score (Score, Clearance %, Description)

    • = 0-24% = Poor Response
    • = 25-49% = Fair Response
    • = 50-74% = Good Response
    • = 75-94% = Excellent Response
    • = >95% = CompleteResponse

Secondary outcomes

  1. 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

    Time frame: 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

    During the 2nd Treatment Visit and all subsequent study visits (treatment and follow-up), Subject Satisfaction Surveys were obtained from all subjects. The scale used to evaluate subject satisfaction is a Likert-type rating Scale and follows -2, -1, 0, 1, 2 for responses of Extremely Dissatisfied, Somewhat Dissatisfied, Neither Satisfied nor Dissatisfied, Somewhat Satisfied and Extremely Satisfied respectfully. The scores are stratified according to treatment group.

Sponsors and collaborators

Lead sponsor

Candela Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2018
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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