Safety and Efficacy Evaluation of Erbium Treatment

Palomar Medical Technologies

Status

Unknown

Conditions

Skin Aging

Treatments

Device: Erbium laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT00766376

ERf-02

Details and patient eligibility

About

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

Full 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.

Enrollment

151 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.