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

Early Phase 1CompletedNCT04054011

University of California, San Diego15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adiposity

Interventions

Deoxycholic AcidDRUG

Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 18 to 65 2. Discrete area of mild-to-moderate excess upper inner thigh fat, amenable to treatment at the discretion of the investigator 3. 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) 4. Body mass index (BMI) less than 30 kg/m2 5. Stable body weight for previous 6 months (weight within 10 pounds of baseline) 6. Subjects must be in stable health, as confirmed by medical history, per investigator judgment 7. Subjects must be able to read, sign, and understand the informed consent 8. Subjects must we willing to avoid any other treatments to the inner thigh, including cryolipolysis and liposuction, during the study period. 9. Subjects must be willing to avoid changes in diet or exercise, any weight loss program, and any weight loss supplements, during the study period. 10. Subjects must be able and willing to avoid anticoagulation (aspirin, warfarin, heparin, rivaroxaban) for 1 week prior to each study treatment Exclusion Criteria: 1. History of treatment for inner thigh fat, including cryolipolysis, noninvasive body contouring or liposuction in the last year 2. Previous trauma or surgery to pelvis or thighs 3. Subjects with an unstable medical condition, as deemed by the investigator 4. Women who are pregnant or lactating or plan to become pregnant during the study period 5. Lymphedema or edema of thigh 6. Excessive skin laxity in the treatment area, as judged by the investigator 7. Severe thigh cellulite 8. Subjects with any disease in the treatment area, such as dermatologic disease, that may be exacerbated by the study treatment 9. Subjects with any condition that may impair the evaluation of inner thigh fat 10. Subjects with known bleeding diathesis 11. 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

Locations (1)

University of California San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

1. Any adverse event (AE) ascertained by patient report or physician evaluation 2. One or more serious adverse events (SAE) as defined by CTCAEv4 3. Adverse events leading to study drug discontinuation.

Time frame: Baseline to 12 weeks after last treatment

Thigh Circumference Change

change in thigh circumference as measured by tape measure

Time frame: 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

Time frame: 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.

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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