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

Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273961

Enrollment

Registered

2011-01-11

Start date

2010-12-31

Completion date

2012-01-31

Last updated

2012-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laxity of Skin

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.

Interventions

DEVICEAuraLevée 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026