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Sponsored by: |
Palomar Medical Technologies, Inc. |
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Information provided by: | Palomar Medical Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00766376 |
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
Condition | Intervention |
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Photodamaged Skin Aged Skin |
Device: Device - erbium laser |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 250 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures.
Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Scripps Clinic Laser & Cosmetic Dermatology | |
San Diego, California, United States, 92130 | |
United States, Massachusetts | |
Palomar Medical Technologies, Inc. | |
Burlington, Massachusetts, United States, 01803 | |
Brooke Seckel, MD | |
Concord, Massachusetts, United States, 01742 | |
United States, New Hampshire | |
Skin & Laser Surgery Center | |
Nashua, New Hampshire, United States, 03060 | |
United States, Texas | |
The University of Texas Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75390 |
Responsible Party: | Palomar Medical Technologies, Inc. ( Medical Director ) |
Study ID Numbers: | ERf-02 |
Study First Received: | September 30, 2008 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00766376 |
Health Authority: | United States: Food and Drug Administration |