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Completed

NCT Number: NCT01279226

Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

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.

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Key information

Conditions

Laxity of Skin

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser Treatment Center

Kirkland, Washington, 98034, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Auralevée device

Device

Single treatment with Auralevée device.

Primary outcomes

  1. Improved cosmesis

    Time frame: 2-6 timepoints from 4 days to 6 months

    Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.

Sponsors and collaborators

Lead sponsor

Rocky Mountain Biosystems, Inc.

Industry

Registry information

Official study title

Radiofrequency Magnetic Induction Device for Use in Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 19, 2011
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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