Safety and Efficacy Evaluation of Erbium Treatment

Skin Aging Clinical Trial

Official title:

Safety and Efficacy Evaluation of Fractional Erbium Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00766376
• Other study ID #: ERf-02
• Status: Active, not recruiting
• Phase: N/A
• First received: September 30, 2008
• Last updated: January 6, 2010
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Palomar Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 151
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Aging

Intervention

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

Locations

Country	Name	City	State
United States	Palomar Medical Technologies, Inc.	Burlington	Massachusetts
United States	Brooke Seckel, MD	Concord	Massachusetts
United States	The University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Skin & Laser Surgery Center	Nashua	New Hampshire
United States	Scripps Clinic Laser & Cosmetic Dermatology	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Palomar Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.		participants at three months	No
Secondary	Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.		participants at three months	No