Safety and Efficacy Evaluation of Erbium Treatment

NCT00766376 | Unknown Results

• 1 other identifier: ERf-02
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.

  participants at three months

Interventions

Erbium laser DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palomar Medical Technologies, Inc.: lead

Study Sites (5)

Scripps Clinic Laser & Cosmetic Dermatology

San Diego, California, 92130, United States

Location

Palomar Medical Technologies, Inc.

Burlington, Massachusetts, 01803, United States

Location

Brooke Seckel, MD

Concord, Massachusetts, 01742, United States

Location

Skin & Laser Surgery Center

Nashua, New Hampshire, 03060, United States

Location

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Palomar Medical Technologies, Inc.

stimberlake@palomarmedical.com

781-993-2414

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 3, 2008
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 29, 2010
• Results First Posted: January 29, 2010

Record last verified: 2010-01

Locations

US (5)