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Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

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ClinicalTrials.gov Identifier: NCT02592993
Recruitment Status : Unknown
Verified February 2017 by Syneron Medical.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Tracking Information
First Submitted Date  ICMJE October 28, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date February 23, 2017
Actual Study Start Date  ICMJE May 23, 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
Efficacy of the PicoWayTM treatment [ Time Frame: from day 0 up to 13 months ]
assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02592993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • Safety of the PicoWayTM [ Time Frame: from day 0 up to 13 months ]
    assessed by study investigator during all study visits (treatments and follow-up).
  • efficacy of the PicoWayTM fractional treatment by the investigator [ Time Frame: after 3 weeks up to 13 months ]
    assessed by study investigator during all study visits (starting from the second treatment).
  • Evaluate investigator satisfaction post treatments [ Time Frame: after 46 weeks and after 52 weeks ]
    assessed by investigator satisfaction post treatments
  • subject satisfaction post treatments [ Time Frame: after 46 weeks and after 52 weeks ]
    assessed by subject satisfaction post treatments.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars
Official Title  ICMJE Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Treatment of Acne Scars
Brief Summary Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.
Detailed Description

Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow‐up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.

Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Scars - Mixed Atrophic and Hypertrophic
Intervention  ICMJE Device: PicoWay device
The PicoWay base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier.
Study Arms  ICMJE Experimental: PicoWay treatment to all subjects
Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWay device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow‐up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Intervention: Device: PicoWay device
Publications * Hoang Viet M, Derreumaux P, Li MS, Roland C, Sagui C, Nguyen PH. Picosecond dissociation of amyloid fibrils with infrared laser: A nonequilibrium simulation study. J Chem Phys. 2015 Oct 21;143(15):155101. doi: 10.1063/1.4933207.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 13, 2016)
53
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2015)
60
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy female and male subjects between 18 to 75 years of age
  2. Has Fitzpatrick skin type I-VI
  3. Subjects seeking treatment for acne scars and wishes to undergo laser treatments for improvement
  4. Have bilateral moderate to severe facial acne scars
  5. Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
  6. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
  7. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
  8. Informed consent process is completed and subject consent is signed

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
  2. Hypersensitivity to light exposure
  3. Active sun tan in facial area
  4. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
  5. Is taking medication(s) for which sunlight is a contraindication
  6. Has a history of squamous cell carcinoma or melanoma
  7. History of keloid scarring, abnormal wound healing and / or prone to bruising
  8. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
  9. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness.
  10. A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months
  11. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
  12. Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
  13. Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
  14. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02592993
Other Study ID Numbers  ICMJE DHF17261
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Syneron Medical
Study Sponsor  ICMJE Syneron Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Syneron Medical
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP