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
|Condition or disease||Intervention/treatment||Phase|
|Brassiere Strap Fat (BSF) Bra Strap Fat (BSF)||Drug: Deoxycholic Acid||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
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
|Contact: Sidra Saeed, MSemail@example.com|
|United States, New York|
|JUVA Skin & Laser Center||Recruiting|
|New York, New York, United States, 10022|
|Contact: Sidra Saeed, MS 212-688-5882 firstname.lastname@example.org|
|Principal Investigator: Bruce E Katz, MD|
|Principal Investigator:||Bruce E Katz, MD||Juva Skin & Laser Center|