Status:
COMPLETED
Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars
Lead Sponsor:
Cynosure, Inc.
Conditions:
Scars
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.
Eligibility Criteria
Inclusion
- Is a healthy male or female between 18 and 85 years old
- Has unwanted scars not including atrophic scars and wishes to undergo laser treatments.
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
- Has Fitzpatrick skin types I to IV.
Exclusion
- The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- The subject has active or localized systemic infections.
- The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
- The subject has used Accutane within 6 months prior to enrollment.
- The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- The subject has a history of keloids.
- The subject has evidence of compromised wound healing.
- The subject has a history of squamous cell carcinoma or melanoma.
- The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- The subjects has an allergy to lidocaine and epinephrine.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01813786
Start Date
December 1 2012
End Date
December 1 2013
Last Update
October 28 2020
Active Locations (1)
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1
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016