Skin Aging Clinical Trial
Official title:
Safety and Efficacy Evaluation of Fractional Erbium Treatment
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
Status | Active, not recruiting |
Enrollment | 151 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy male and female Adults (18 years or older). - Subjects who can read, understand, and sign the Informed Consent Form. - Subjects willing and able to comply with all study requirements. Exclusion Criteria: - Subjects with active localized or systemic infections. - Immunocompromised subjects. - Subjects with coagulation disorder. - History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs). - Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study). - In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits. - Use of Accutane® within the past 6 months. - Subjects with a history of radiation therapy to the treatment area. - Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments. - Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Palomar Medical Technologies, Inc. | Burlington | Massachusetts |
United States | Brooke Seckel, MD | Concord | Massachusetts |
United States | The University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Skin & Laser Surgery Center | Nashua | New Hampshire |
United States | Scripps Clinic Laser & Cosmetic Dermatology | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Palomar Medical Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. | participants at three months | No | |
Secondary | Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. | participants at three months | No |
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