Status:

COMPLETED

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

Lead Sponsor:

Cynosure, Inc.

Conditions:

Scars

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • Is a healthy male or female between 18 and 85 years old.
  • Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.
  • Is willing to consent to participate in the study.
  • 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

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

Key Trial Info

Start Date :

June 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2014

Estimated Enrollment :

33 Patients enrolled

Trial Details

Trial ID

NCT01811030

Start Date

June 1 2012

End Date

May 1 2014

Last Update

January 14 2021

Active Locations (1)

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1

Laser & Skin Surgery Center of New York

New York, New York, United States, 10016