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Trial record 42 of 83 for:    acne AND Acne Scars

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

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.

Condition or disease Intervention/treatment Phase
Acne Scars - Mixed Atrophic and Hypertrophic Device: PicoWay device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Treatment of Acne Scars
Actual Study Start Date : May 23, 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Evaluate investigator satisfaction post treatments [ Time Frame: after 46 weeks and after 52 weeks ]
    assessed by investigator satisfaction post treatments

  4. subject satisfaction post treatments [ Time Frame: after 46 weeks and after 52 weeks ]
    assessed by subject satisfaction post treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02592993


Locations
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United States, Illinois
Dr. Jerome M. Garden
Chicago, Illinois, United States, 60611
United States, New York
New York Laser & Skin Care
New York, New York, United States, 10028
United States, Pennsylvania
Dr. Eric F. Bernstein
Ardmore, Pennsylvania, United States, 19003
Sponsors and Collaborators
Syneron Medical

Publications:
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Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT02592993     History of Changes
Other Study ID Numbers: DHF17261
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical