755nm Alex Laser for Treatment of Stretch Marks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01745211
First received: December 6, 2012
Last updated: April 9, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01745211     History of Changes
Other Study ID Numbers: CYN12-PICO-STRIAE_RG4
Study First Received: December 6, 2012
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 20, 2014