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Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01811030
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Brief Summary:
Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.

Condition or disease Intervention/treatment Phase
Scars Device: 755nm Alexandrite Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: 755nm Alexandrite Laser
755nm Alexandrite Laser
Device: 755nm Alexandrite Laser
755nm Alexandrite Laser




Primary Outcome Measures :
  1. Photographic Evaluation of Scar Clearance [ Time Frame: up to 3 months post last treatment ]
    2D and 3D photography


Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 4 months post last treatment ]

Other Outcome Measures:
  1. Subject biopsy sampling [ Time Frame: up to 4 months post treatment ]
    histological evaluation of tissue samples pre-treatment and 3-4 months post treatment to assess safety and tolerability.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is a healthy male or female between 18 and 85 years old.
  2. Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.
  3. Is willing to consent to participate in the study.
  4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

  1. Is hypersensitive to light exposure.
  2. Has active localized or systemic infection.
  3. Is taking medication(s) for which sunlight is a contraindication.
  4. Has a history of squamous cell carcinoma or melanoma.
  5. Has a history of keloid scarring.
  6. 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.
  7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
  9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
  10. Has any other reason determined by the physician to be ineligible to participate in the 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): NCT01811030


Locations
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United States, New York
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Patricia Krantz Cynosure, Inc.

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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01811030     History of Changes
Other Study ID Numbers: CYN12-PICO_SCARS_RG06
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015