Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

Completed · Not applicable

Conditions studied: Laxity of Skin

In brief

The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Key facts

Study ID

NCT01279226

Run by

Rocky Mountain Biosystems, Inc.

People needed

40

Starts

2010-02-01

Expected to finish

2011-02-01

Last updated by the study team

2012-12-03

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female at least 21 years old,
• Apparently healthy,
• Informed consent signed by the subject.

You may not qualify if…

• Tobacco smokers,
• History of skin hypersensitivity,
• Current skin disorder or infection (e.g., herpes simplex),
• Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
• Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
• Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
• The current or recent use (within the past 12 months) of isotretinoin,
• Pregnancy or breast feeding,
• Insulin dependent diabetic subjects,
• Oxygen dependent subjects,
• Subjects with severe chronic illness, scleroderma, or lupus,
• Subjects with open sores or scars in the treatment region, or
• Subjects with ischemia in the treatment region.

Where it is running

• Laser Treatment Center — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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