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

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ClinicalTrials.gov Identifier: NCT04089722
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Bruce E. Katz, Juva Skin & Laser Center

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 13, 2019
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE July 26, 2019
Estimated Primary Completion Date June 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
Reduction of Anterior/Posterior Axilla Fat [ Time Frame: 6 months ]
Composite improvements of 1 or more grades in BSF observed on both the Clinician- and Patient-Reported BSF Rating Scales
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the "Bra Strap Fat" Region
Official Title  ICMJE Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the Anterior and Posterior Aspect of the Axilla "Bra Strap Fat"
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brassiere Strap Fat (BSF)
  • Bra Strap Fat (BSF)
Intervention  ICMJE 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 Name: Kybella
Study Arms  ICMJE 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.
Intervention: Drug: Deoxycholic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 11, 2020
Estimated Primary Completion Date June 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sidra Saeed, MS 2124219501 sidras@juvaskin.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04089722
Other Study ID Numbers  ICMJE 60E56
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bruce E. Katz, Juva Skin & Laser Center
Study Sponsor  ICMJE Juva Skin & Laser Center
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Bruce E Katz, MD Juva Skin & Laser Center
PRS Account Juva Skin & Laser Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP