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

NCT04054011 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 181524
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Adiposity

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline to 12 weeks after last treatment

• Thigh Circumference Change

  change in thigh circumference as measured by tape measure

  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

  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.

  12 weeks

Secondary Outcomes (1)

• Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs

  12 weeks

Study Arms (1)

deoxycholic acid

EXPERIMENTAL

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.)

Drug: Deoxycholic Acid

Interventions

Deoxycholic Acid DRUG

Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous

deoxycholic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Deoxycholic Acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Limitations and Caveats

Due to the COVID-19 pandemic, three subjects could not complete their 12-week follow-up visits.

Results Point of Contact

• Title: Joyce Yuan, MD
• Organization: UCSD Dermatology

joyce.yuan2@ucsf.edu

(858) 657-8322

Study Officials

• Arisa Ortiz, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: All subjects will receive deoxycholic acid (1-4 treatment sessions) for treatment of upper inner thigh fat.

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: August 13, 2019
• Study Start: July 5, 2019
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: January 20, 2021
• Results First Posted: November 13, 2020

Record last verified: 2020-12

Locations

US (1)