Status:
UNKNOWN
Safety and Efficacy Evaluation of Erbium Treatment
Lead Sponsor:
Palomar Medical Technologies, Inc.
Conditions:
Skin Aging
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
Detailed Description
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 foll...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00766376
Start Date
July 1 2007
End Date
July 1 2009
Last Update
January 29 2010
Active Locations (5)
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1
Scripps Clinic Laser & Cosmetic Dermatology
San Diego, California, United States, 92130
2
Palomar Medical Technologies, Inc.
Burlington, Massachusetts, United States, 01803
3
Brooke Seckel, MD
Concord, Massachusetts, United States, 01742
4
Skin & Laser Surgery Center
Nashua, New Hampshire, United States, 03060