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PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774849
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Candela Corporation

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

Condition or disease Intervention/treatment Phase
Benign Pigmented Lesions Facial Wrinkles Device: PicoWay™ 532nm fractional handpiece Device: PicoWay™ 730nm wavelength Device: PicoWay™ 1064nm fractional handpiece Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Picoway™ 532nm fractional handpiece
Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece
Device: PicoWay™ 730nm wavelength
PicoWay™ Laser System is picosecond 532/1064/785 laser

Experimental: PicoWay™ 730nm wavelength
PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength.
Device: PicoWay™ 532nm fractional handpiece
PicoWay™ Laser System is picosecond 532/1064/785 laser

Experimental: PicoWay ™1064nm fractional handpiece
Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece
Device: PicoWay™ 1064nm fractional handpiece
PicoWay™ Laser System is picosecond 532/1064/785 laser




Primary Outcome Measures :
  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 assessed by blinded photographic evaluation using a 5-Point Pigment Clearance Score [ Time Frame: Baseline to 12-week follow-Up Visit ]

    5-Point Pigment Clearance Score 0 0% No improvement

    1. 1-24% Trace to mild response
    2. 25-49% Moderate response
    3. 50-74% Good response
    4. 75-100% Excellent response



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774849


Locations
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United States, Massachusetts
Syneron Candela Institute for Excellence Recruiting
Wayland, Massachusetts, United States, 01778
Contact: Megan Murphy, RN    508-358-0357    meghanm@candelamedical.com   
Principal Investigator: Khalil A. Khatri, MD         
Principal Investigator: Konika Schallen, MD         
Sponsors and Collaborators
Candela Corporation
Investigators
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Study Director: Joseph Lowery Director of Clinical Affairs, Candela Corporation
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Responsible Party: Candela Corporation
ClinicalTrials.gov Identifier: NCT03774849    
Other Study ID Numbers: PWY18010
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes