Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures

Not Applicable

Completed

• Conditions: Laxity of Skin

• Registration Number: NCT01273961
• Lead Sponsor: Rocky Mountain Biosystems, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-11
• Primary Completion: 2011-08
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female 21 to 70 years old,
• For females, at least 9 months post-partum,
• Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
• For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
• Apparently healthy,
• Informed consent signed by the subject.

Exclusion Criteria

• History of skin hypersensitivity,
• Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
• Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
• Suffering from hormonal imbalance which may affect weight or cellulite,
• Subjects with 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,
• Infectious diseases (such as HIV) present,
• Are a tobacco smoker,
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in cosmesis	1 and 3 months	Improvement in cosmesis will be assessed by scoring photographs taken before and 1 and 3 months after treatment. Circumference changes will be measured and compared.

Trial Locations

Locations (1)

Center for Cosmetic Surgery; 🇺🇸 Golden, Colorado, United States