Status:
COMPLETED
Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat
Lead Sponsor:
University of California, San Diego
Conditions:
Adiposity
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 aci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04054011
Start Date
July 5 2019
End Date
May 19 2020
Last Update
January 20 2021
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92122