Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the "Bra Strap Fat" Region

Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the Anterior and Posterior Aspect of the Axilla "Bra Strap Fat"

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 .

Study Overview

• Status: Completed
• Conditions: Brassiere Strap Fat (BSF); Bra Strap Fat (BSF)
• Intervention / Treatment: Drug: Deoxycholic Acid

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Juva Skin & Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Open-Label: Deoxycholic Acid Injections; Deoxycholic Acid Injections (dose strength: 2 mg/cm2) via subcutaneous injections into posterior and/or anterior axillary roll adiposity. Patients will receive 10 mL or less (≤100 mg) of study drug per treatment administered in 0.2-mL injections with a 30-gauge, 0.5-in needle attached to a 1-mL syringe at 1.0-cm spacing using a customized grid. Up to 6 treatments (30 ± 7 days apart) will be permitted, but fewer can be allowed because of efficacy (insufficient BSF to inject, patient satisfaction with treatment) or safety/tolerability concerns.

Drug: Deoxycholic 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.; Other Names: Kybella

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Anterior/Posterior Axilla Fat	Composite improvements of 1 or more grades in BSF observed on both the Clinician- and Patient-Reported BSF Rating Scales	6 months

Collaborators and Investigators

• Sponsor: Juva Skin & Laser Center
• Collaborators: Allergan
• Investigators: Principal Investigator: Bruce E Katz, MD, Juva Skin & Laser Center

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2019
• Primary Completion (Actual): June 11, 2020
• Study Completion (Actual): October 22, 2020

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: 60E56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes