Safety and Efficacy Evaluation of Erbium Treatment

Status unconfirmed · Not applicable

Conditions studied: Skin Aging

In brief

The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.

Key facts

Study ID

NCT00766376

Run by

Palomar Medical Technologies, Inc.

People needed

151

Starts

2007-07-01

Expected to finish

2009-07-01

Last updated by the study team

2010-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scripps Clinic Laser & Cosmetic Dermatology — San Diego, California, United States
• Palomar Medical Technologies, Inc. — Burlington, Massachusetts, United States
• Brooke Seckel, MD — Concord, Massachusetts, United States
• Skin & Laser Surgery Center — Nashua, New Hampshire, United States
• The University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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