Unknown statusInterventionalNot ApplicableUpdated Oct 13, 2022
Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars | NCT01811030 | Trialant
CompletedInterventionalNot ApplicableUpdated Jan 14, 2021
Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars
ClinicalTrials.gov ID
NCT01811030
Lead Sponsor
Cynosure, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
33Actual
Last Update Posted
Jan 14, 2021Actual
Start Date
Jun 2012
Primary Completion Date
May 2014Actual
Completion Date
May 2014Actual
Brief Summary
Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.
Scars
755nm Alexandrite Laser
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.