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

• Status: Completed
• Trial end date: 2020-05-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Deoxycholic Acid

Criteria

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