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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

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 .

Condition or disease Intervention/treatment Phase
Brassiere Strap Fat (BSF) Bra Strap Fat (BSF) Drug: Deoxycholic Acid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the Anterior and Posterior Aspect of the Axilla "Bra Strap Fat"
Actual Study Start Date : July 26, 2019
Estimated Primary Completion Date : June 11, 2020
Estimated Study Completion Date : June 11, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Kybella




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089722


Contacts
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Contact: Sidra Saeed, MS 2124219501 sidras@juvaskin.com

Locations
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United States, New York
JUVA Skin & Laser Center Recruiting
New York, New York, United States, 10022
Contact: Sidra Saeed, MS    212-688-5882    sidras@juvaskin.com   
Principal Investigator: Bruce E Katz, MD         
Sponsors and Collaborators
Juva Skin & Laser Center
Allergan
Investigators
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Principal Investigator: Bruce E Katz, MD Juva Skin & Laser Center

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Responsible Party: Bruce E. Katz, Medical Director, Juva Skin & Laser Center
ClinicalTrials.gov Identifier: NCT04089722     History of Changes
Other Study ID Numbers: 60E56
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents