Safety and Efficacy Evaluation of Erbium Treatment - Full Text View

Sponsored by:	Palomar Medical Technologies, Inc.
Information provided by:	Palomar Medical Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00766376

Purpose

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

Condition	Intervention
Photodamaged Skin Aged Skin	Device: Device - erbium laser

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Palomar Medical Technologies, Inc.:

Primary Outcome Measures:

Overall improvement in aging and/or photodamaged skin. Safety will be based on clinician eval at each F/U visit. Improvement of aged and/or photodamaged skin will be assessed based on subject and clinical observation and photographic imaging. [ Time Frame: up to 1 year post treatment, or until resolution of all AEs ] [ Designated as safety issue: No ]

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)

Intervention Details:

Erbium laser treatment. Each subject will undergo up to 6 treatment sessions

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766376

Locations

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

Sponsors and Collaborators

Palomar Medical Technologies, Inc.

More Information

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

ClinicalTrials.gov processed this record on January 16, 2009