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

• Status: Completed
• Trial end date: 2020-10-22
• Target enrollment: 0
• Participant gender: Female

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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Juva Skin & Laser Center
• Collaborator: Allergan
• Treatments: Deoxycholic Acid

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