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

NCT ID: NCT01273961

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-01-31

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.

Conditions

Laxity of Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

AuraLevée treatment

A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rocky Mountain Biosystems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Wolfe, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Cosmetic Surgery

Stephen Flock, PhD

Role: STUDY_DIRECTOR

Rocky Mountain Biosystems, Inc.

Locations

Center for Cosmetic Surgery

Golden, Colorado, United States

Countries

United States

Other Identifiers

0310-0003

Identifier Type: -

Identifier Source: org_study_id