Overview

This trial is active, not recruiting.

Condition skin aging
Treatment erbium laser
Sponsor Palomar Medical Technologies, Inc.
Start date July 2007
End date July 2009
Trial size 151 participants
Trial identifier NCT00766376, ERf-02

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.
time frame: participants at three months

Secondary Outcomes

Measure
Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.
time frame: participants at three months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Safety and Efficacy Evaluation of Fractional Erbium Treatment
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Palomar Medical Technologies, Inc..