Adiposity
Conditions
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.
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.
Interventions
DRUGDeoxycholic Acid
Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will receive deoxycholic acid (1-4 treatment sessions) for treatment of upper inner thigh fat.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Baseline to 12 weeks after last treatment | 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. |
| Thigh Circumference Change | Baseline to 12 weeks after last treatment | change in thigh circumference as measured by tape measure |
| Upper Inner Thigh Skin Fold Thickness Change | Baseline to 12 weeks after last treatment | change in upper inner thigh skin fold thickness as measured by body fat calipers |
| Change in Thigh Gap | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs | 12 weeks | 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 |
Countries
United States
Participant flow
Pre-assignment details
No significant events pertaining to pre-assignment.
Participants by arm
| Arm | Count |
|---|---|
| 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.)
Deoxycholic Acid: Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID | 3 |
Baseline characteristics
| Characteristic | Deoxycholic Acid | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 15 Participants | — |
| Age, Continuous | 35 years | — |
| BMI | 24 kg/m^2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 Participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deoxycholic Acid | Change in Thigh Gap | 1.6 centimeters | Standard Deviation 0.8 |
Primary
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.
Time frame: Baseline to 12 weeks after last treatment
Population: AE in number of participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid | Number of Participants With Adverse Events | ransient subcutaneous nodules | 08 participants |
| Deoxycholic Acid | Number of Participants With Adverse Events | injection-site urticaria | 01 participants |
| Deoxycholic Acid | Number of Participants With Adverse Events | Temporary numbness | 02 participants |
Primary
Thigh Circumference Change
change in thigh circumference as measured by tape measure
Time frame: Baseline to 12 weeks after last treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid | Thigh Circumference Change | average change from baseline at 4 week | -1.8 cm | Standard Deviation 0.5 |
| Deoxycholic Acid | Thigh Circumference Change | average change from baseline at 12 week | -2.2 cm | Standard Deviation 0.6 |
Primary
Upper Inner Thigh Skin Fold Thickness Change
change in upper inner thigh skin fold thickness as measured by body fat calipers
Time frame: Baseline to 12 weeks after last treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid | Upper Inner Thigh Skin Fold Thickness Change | average change from baselineat 4 week | -7.3 mm | Standard Deviation 2.1 |
| Deoxycholic Acid | Upper Inner Thigh Skin Fold Thickness Change | average change from baseline at 12 week | -8.8 mm | Standard Deviation 2.53 |
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
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid | Percent Accuracy by Three Blinded Physicians in Correctly Identifying Before-and-after Photographs | 83 percent accuracy of post treatment photo |