Safety and Efficacy Evaluation of Erbium Treatment

• ClinicalTrials.gov Identifier: NCT00766376
• Recruitment Status: Unknown
• First Posted: October 3, 2008
• Results First Posted: January 29, 2010
• Last Update Posted: January 29, 2010
• Sponsor: Palomar Medical Technologies, Inc.
• Information provided by: Palomar Medical Technologies, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Skin Aging	Device: Erbium laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 151 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy Evaluation of Fractional Erbium Treatment
• Study Start Date: July 2007
• Estimated Primary Completion Date: July 2009
• Estimated Study Completion Date: July 2009

Arms and Interventions

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. [ Time Frame: participants at three months ]
   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.

Secondary Outcome Measures :

1. Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. [ Time Frame: participants at three months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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: Medical Director, Palomar Medical Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT00766376
• Other Study ID Numbers: ERf-02
• First Posted: October 3, 2008
• Results First Posted: January 29, 2010
• Last Update Posted: January 29, 2010
• Last Verified: January 2010