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

December 6, 2012
April 9, 2014
January 2012
November 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01745211 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
755nm Alex Laser for Treatment of Stretch Marks
Not Provided

Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Striae
Device: 755nm Alexandrite Laser
755nm Alexandrite laser with modified and standard handpiece
  • Experimental: 755nm Alexandrite Laser
    755nm Alexandrite laser (standard handpiece)
    Intervention: Device: 755nm Alexandrite Laser
  • Experimental: 755nm Alexandrite laser with modified handpiec
    Device: 755nm Alexandrite laser with modified handpiece
    Intervention: Device: 755nm Alexandrite Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01745211
CYN12-PICO-STRIAE_RG4
No
Cynosure, Inc.
Cynosure, Inc.
Not Provided
Study Director: Patricia Krantz Cynosure, Inc.
Cynosure, Inc.
April 2014

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