Clinical trial NCT04054011: Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat
Official title: Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Adiposity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive deoxycholic acid (1-4 treatment sessions) for treatment of upper inner thigh fat.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline to 12 weeks after last treatment
measure: Thigh Circumference Change
timeFrame: Baseline to 12 weeks after last treatment
measure: Upper Inner Thigh Skin Fold Thickness Change
timeFrame: Baseline to 12 weeks after last treatment
measure: Change in Thigh Gap
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Arisa Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References: