Early Phase 1
N=15
Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat
Adiposity
Bottom Line
View on ClinicalTrials.gov: NCT04054011 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Adverse Events — 08; 01; 02 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Deoxycholic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
08; 01; 02 | — |
| PRIMARY Thigh Circumference Change |
-1.8; -2.2 | — |
| PRIMARY Upper Inner Thigh Skin Fold Thickness Change |
-7.3; -8.8 | — |
| PRIMARY Change in Thigh Gap |
1.6 | — |
| SECONDARY Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs |
83 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04054011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.