Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat

Study Overview
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Brief Summary
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This is a phase I, open-label clinical trial evaluating the safety and efficacy of deoxycholic acid injection for reduction of upper inner thigh fat.

Detailed Description
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Unwanted upper inner thigh fat is a common aesthetic complaint from patients, and current treatment options include liposuction and cryolipolysis (CoolSculpting, Allergan, Irvine, CA). Deoxycholic acid (Kybella, Allergan, Irvine, CA) is an FDA-approved injectable for the treatment of excess submental fat. At this time, it is not known if deoxycholic acid may be a safe and effective treatment for upper inner thigh fat. The proposed clinical trial will evaluate the safety and efficacy of deoxycholic acid for reduction of upper inner thigh fat. In this single-arm, open-label safety and efficacy study, 15 subjects with excess upper inner thigh fat will receive 1-4 treatment sessions of subcutaneously injected deoxycholic acid. Subjects will be followed for 12 weeks after last treatment. Adverse events will be monitored. Efficacy will be objectively measured by change in thigh circumference; change in upper inner thigh skin fold thickness; increase in thigh gap; and percent accuracy by three blinded physicians in correctly identifying baseline photographs, upon independent review of before-and-after clinical photographs of the treatment area. Patient satisfaction related to the study treatment will be assessed with a Subject Self-Rating Scale throughout the study, and with a Post-Treatment Satisfaction Questionnaire.

Official Title
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Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat

Conditions
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Adiposity

Intervention / Treatment
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* Drug: Deoxycholic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 to 65 Discrete area of mild-to-moderate excess upper inner thigh fat, amenable to treatment at the discretion of the investigator Subjects who score 0 (extremely dissatisfied) to 2 (slightly dissatisfied) on a Subject Self-Rating Scale, pertaining to upper inner thigh fat, with the scale ranging from 0 (extremely dissatisfied) to 6 (extremely satisfied) Body mass index (BMI) less than 30 kg/m2 Stable body weight for previous 6 months (weight within 10 pounds of baseline) Subjects must be in stable health, as confirmed by medical history, per investigator judgment Subjects must be able to read, sign, and understand the informed consent Subjects must we willing to avoid any other treatments to the inner thigh, including cryolipolysis and liposuction, during the study period. Subjects must be willing to avoid changes in diet or exercise, any weight loss program, and any weight loss supplements, during the study period. Subjects must be able and willing to avoid anticoagulation (aspirin, warfarin, heparin, rivaroxaban) for 1 week prior to each study treatment Exclusion Criteria: History of treatment for inner thigh fat, including cryolipolysis, noninvasive body contouring or liposuction in the last year Previous trauma or surgery to pelvis or thighs Subjects with an unstable medical condition, as deemed by the investigator Women who are pregnant or lactating or plan to become pregnant during the study period Lymphedema or edema of thigh Excessive skin laxity in the treatment area, as judged by the investigator Severe thigh cellulite Subjects with any disease in the treatment area, such as dermatologic disease, that may be exacerbated by the study treatment Subjects with any condition that may impair the evaluation of inner thigh fat Subjects with known bleeding diathesis Subjects with any known hypersensitivity to Kybella (deoxycholic acid) or any of the inactive ingredients: benzyl alcohol, dibasic sodium phosphate, sodium chloride, sodium hydroxide, hydrochloric acid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive deoxycholic acid (1-4 treatment sessions) for treatment of upper inner thigh fat.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deoxycholic acid<br>Deoxycholic acid (Kybella) 10 mg/ mL will be injected subcutaneously, targeting the medial thigh deep fat compartment (pre-fascial). Subjects will receive deoxycholic acid 2 mg/ cm2, with injections of 0.2 mL spaced evenly 1 cm apart within the treatment area. Bilateral thighs will be treated. Each treatment will consist of a maximum of 8 mL (40 injection sites) of the study drug, with a maximum of 4 mL (20 injection sites) of the study drug for each thigh. Subjects will undergo 1-4 treatment sessions, each treatment session separated by 6 weeks +/- 1 week (Treatment #2, #3, or #4 will be pursued if patient desires more treatment, and if there is sufficient fat for treatment, per investigator's judgment.) | Drug: Deoxycholic Acid<br>* Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Any adverse event (AE) ascertained by patient report or physician evaluation One or more serious adverse events (SAE) as defined by CTCAEv4 Adverse events leading to study drug discontinuation. | Baseline to 12 weeks after last treatment | 
| Thigh Circumference Change | change in thigh circumference as measured by tape measure | Baseline to 12 weeks after last treatment | 
| Upper Inner Thigh Skin Fold Thickness Change | change in upper inner thigh skin fold thickness as measured by body fat calipers | Baseline to 12 weeks after last treatment | 
| Change in Thigh Gap | Thigh gap, measured with a handheld soft ruler, was defined as the horizontal distance between baseline sites of maximum bulge, with feet at standardized distance apart. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs | 3 blinded physicians identified the before and after photos and the percentage number was 83% for percent accuracy of the results. The percent accuracy was calculated for the entire Arm/Group rather than for each participant | 12 weeks |