Safety and Efficacy Evaluation of Erbium Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Skin Aging
• Intervention / Treatment: Device: Erbium laser

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92130
      • Scripps Clinic Laser & Cosmetic Dermatology
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Palomar Medical Technologies, Inc.
    • Concord, Massachusetts, United States, 01742
      • Brooke Seckel, MD
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Skin & Laser Surgery Center
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.	To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.	participants at three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.	To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.	participants at three months

Collaborators and Investigators

• Sponsor: Palomar Medical Technologies, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Anticipated): July 1, 2009
• Study Completion (Anticipated): July 1, 2009

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 3, 2008

Study Record Updates

• Last Update Posted (Estimate): January 29, 2010
• Last Update Submitted That Met QC Criteria: January 6, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: ERf-02