- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054011
Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92122
- University of California San Diego
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: deoxycholic acid
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.)
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Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: Baseline to 12 weeks after last treatment
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Baseline to 12 weeks after last treatment
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Thigh Circumference Change
Time Frame: Baseline to 12 weeks after last treatment
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change in thigh circumference as measured by tape measure
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Baseline to 12 weeks after last treatment
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Upper Inner Thigh Skin Fold Thickness Change
Time Frame: Baseline to 12 weeks after last treatment
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change in upper inner thigh skin fold thickness as measured by body fat calipers
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Baseline to 12 weeks after last treatment
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Change in Thigh Gap
Time Frame: 12 weeks
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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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs
Time Frame: 12 weeks
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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
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Arisa Ortiz, MD, University of California, San Diego
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181524
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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