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

NCT04089722 | Completed Phase 4 FDA Drug

• 1 other identifier: 60E56
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 .

Conditions

Brassiere Strap Fat (BSF); Bra Strap Fat (BSF)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Open-Label: Deoxycholic Acid Injections

OTHER

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

Interventions

Deoxycholic Acid DRUG

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.

Also known as: Kybella

Open-Label: Deoxycholic Acid Injections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juva Skin & Laser Center: lead
• Allergan: collaborator

Study Sites (1)

JUVA Skin & Laser Center

New York, New York, 10022, United States

Location

MeSH Terms

Interventions

Deoxycholic Acid

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Bruce E Katz, MD

  Juva Skin & Laser Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: July 26, 2019
• Primary Completion: June 11, 2020
• Study Completion: October 22, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)