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

Adiposity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054011
• Other study ID #: 181524
• Status: Completed
• Phase: Early Phase 1
• Start date: July 5, 2019
• Est. completion date: May 19, 2020

Study information

• Verified date: December 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Obesity

Intervention

Drug:
• Deoxycholic Acid
Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Any adverse event (AE) ascertained by patient report or physician evaluation; One or more serious adverse events (SAE) as defined by CTCAEv4; Adverse events leading to study drug discontinuation.	Baseline to 12 weeks after last treatment
Primary	Thigh Circumference Change	change in thigh circumference as measured by tape measure	Baseline to 12 weeks after last treatment
Primary	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
Primary	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	Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs	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	12 weeks