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755nm Alex Laser for Treatment of Stretch Marks

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745211
First Posted: December 10, 2012
Last Update Posted: April 10, 2014
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.
Information provided by (Responsible Party):
Cynosure, Inc.
  Purpose
Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.

Condition Intervention
Striae Device: 755nm Alexandrite Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Photographic evaluation of striae clearance [ Time Frame: up to 3 months post last treatment ]
    both standard and 3D photography will be used


Enrollment: 45
Study Start Date: January 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 755nm Alexandrite Laser
755nm Alexandrite laser (standard handpiece)
Device: 755nm Alexandrite Laser
755nm Alexandrite laser with modified and standard handpiece
Experimental: 755nm Alexandrite laser with modified handpiec
Device: 755nm Alexandrite laser with modified handpiece
Device: 755nm Alexandrite Laser
755nm Alexandrite laser with modified and standard handpiece

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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 striae 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.
  Contacts and Locations
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): NCT01745211


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

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01745211     History of Changes
Other Study ID Numbers: CYN12-PICO-STRIAE_RG4
First Submitted: December 6, 2012
First Posted: December 10, 2012
Last Update Posted: April 10, 2014
Last Verified: April 2014


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