This trial is active, not recruiting.

Condition wrinkles and rhytides
Treatment biofusionary bebe
Sponsor Rocky Mountain Biosystems, Inc.
Start date October 2012
End date July 2013
Trial size 60 participants
Trial identifier NCT01701440, 0310-0017


In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Improvement in cosmesis
time frame: 1 month

Secondary Outcomes

Improvement in cosmesis
time frame: 3 months

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

The inclusion criteria for the study are: - Male or female 21 to 65 years old, - Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms & buttocks 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: The exclusion criteria for the study are: - History of skin hypersensitivity, - Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area, - 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, - 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.

Additional Information

Official title Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
Principal investigator Jerome Garden, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Rocky Mountain Biosystems, Inc..