Brassiere Strap Fat (BSF), Bra Strap Fat (BSF)
Conditions
Brief summary
This study evaluates the safety and efficacy of deoxycholic acid injections to dissolve adipose tissue in the anterior and posterior aspect of the axilla or the so called brassiere strap fat (BSF). Adult females aged 18-65 dissatisfied with their moderate or severe BSF will receive deoxycholic acid (dose strength: 2 mg/cm2) via subcutaneous injections into posterior and/or anterior axillary roll adiposity .
Detailed description
The efficacy and safety of deoxycholic acid injections to dissolve adipose tissue in the submental area have been extensively evaluated. Deoxycholic acid injections have also been used successfully off-label to dissolve adipose tissues in other body areas. Our clinical experience in addition to a few case reports have shown the effectiveness and safety of deoxycholic acid injections to dissolve the adipose tissue in the anterior and posterior aspect of the axilla or the so called brassiere strap fat (BSF). This is a single-center, prospective, single-arm, single-blind trial study. This study is expected to benefit the existing literature by potentially adding a new non-invasive injectable treatment to a condition of excessive adipose tissue in the anterior and posterior aspect of the axilla that until now could only be treated with invasive surgery.
Interventions
DRUGDeoxycholic Acid
The active ingredient in KYBELLA® is synthetic deoxycholic acid. Deoxycholic acid is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat.
Sponsors
Allergan
Juva Skin & Laser Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult female age 18-65 * Subject satisfaction rating score of 0 or 1 * Clinician reported BSF rating score of 2, 3 or 4 * Patient reported BSF rating score of 2, 3 or 4 * Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator. * Willing to withhold additional aesthetic therapies to the proposed treatment area. * Negative urine pregnancy test * Willing to use acceptable methods of contraception throughout the study * Sign an IRB-approved Informed Consent Form prior to any study-related procedures being performed.
Exclusion criteria
* History of any intervention to treat BSF (eg, liposuction, surgery, lipolytic agents) * History of trauma associated with the axillary or upper back area * Severe Skin Laxity Grade or other anatomical feature as assessed within 28 d before randomization, for which reduction in BSF may, in the judgment of the investigator, result in an aesthetically unacceptable outcome * Evidence of any cause of enlargement in the upper back/ axillary roll (eg, tumors, lipomas) other than localized BSF * BMI greater than 35 kg/m2 * A result on coagulation tests (prothrombin time, partial thromboplastin time) obtained within 28 d before randomization indicating the presence of any clinically significant bleeding disorder * Any medical condition (eg, respiratory, cardiovascular, hepatic, neurologic disease, thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the patient's ability to undergo study procedures or give informed consent * History of sensitivity to any components of the study drug * History of sensitivity to topical or local anesthetics (eg, lidocaine, benzocaine, procaine) * Pregnancy * Lactation * Presence of infection at the injection sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Anterior/Posterior Axilla Fat | 6 months | Composite improvements of 1 or more grades in BSF observed on both the Clinician- and Patient-Reported BSF Rating Scales |
Countries
United States
Outcome results
None listed