Safety and Efficacy Evaluation of Erbium Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Palomar Medical Technologies, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Palomar Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00766376
First received: September 30, 2008
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention
Skin Aging
Device: Erbium laser

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of Fractional Erbium Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. [ Time Frame: participants at three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. [ Time Frame: participants at three months ] [ Designated as safety issue: No ]

Enrollment: 151
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:
    Device: Erbium laser
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Medical Director, Palomar Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00766376     History of Changes
Other Study ID Numbers: ERf-02
Study First Received: September 30, 2008
Results First Received: January 6, 2010
Last Updated: January 6, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 31, 2014