Clinical trial NCT00766376: Safety and Efficacy Evaluation of Erbium Treatment
Official title: Safety and Efficacy Evaluation of Fractional Erbium Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Aging
Lead sponsor: Palomar Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.
timeFrame: participants at three months
Secondary outcomes:
measure: Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.
timeFrame: participants at three months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic Laser & Cosmetic Dermatology
state: California
city: Burlington
country: United States
facility: Palomar Medical Technologies, Inc.
state: Massachusetts
city: Concord
country: United States
facility: Brooke Seckel, MD
state: Massachusetts
city: Nashua
country: United States
facility: Skin & Laser Surgery Center
state: New Hampshire
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
References: