Obesity
Conditions
Brief summary
The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits due to the known fat necrosis effects on fat tissue after study drug tissue incubation.
Detailed description
This study is a randomized, double-blind study of 21 subjects. Participants in this study will be healthy, non-obese (BMI \<30) subjects over 25 with two localized, symmetrical, and contralateral areas of fat deposition on the abdomen or flanks and on the buttocks or thighs that have proven resistant to diet and exercise. Each participant will be randomized to one of three groups and will receive 4 series of injections two weeks apart. Multiple injections will be placed in the subdermal fat layer from 1-1.5 cm apart depending on the size of the treatment area. Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections. The study sites will include a symmetric, contralateral area of localized fat deposit on both the upper and lower torso. Clinical evaluations will be performed at each visit. Hematologic and ultrasonographic evaluations will be performed at baseline, at the 3rd treatment (Week 4), and at 6 month follow-up. Histologic evaluations will be performed on select individuals at baseline and at the 3rd treatment (Week 4) visit.
Interventions
DRUGPhosphatidylcholine Deoxycholate
Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections
DRUGSaline
Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 25 and over * BMI of 18.5-29.99 * Two localized areas of fat deposition on the upper and lower torso that have failed on self-reported diet and exercise * The subject is in good health * The subject has the willingness and the ability to understand and provide informed consent
Exclusion criteria
* Under 25 years of age * Pregnancy or Lactation * BMI≥ 30 * Subjects with known eating disorders or a history of weight loss/gain of 5 pounds or more within the past 6 months * Subjects with hepatrophy, nephopathy, diabetes, hyperthyroidism, neoplasias, AIDS or other immuno-compromised illness, allergies to eggs or soy, poorly controlled hypertension, or autoimmune disease * Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months * Subjects with an open, non-healing sore or infection near site of injection * Subjects with active eczema or psoriasis * Subjects who are unable to understand the protocol or to give informed consent * Subjects with mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Phosphatidylcholine and Deoxycholate Subcutaneous Injections for Localized Fat Removal. | 1 year | The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| C Phosphatidylcholine Deoxycholate Phosphatidylcholine Deoxycholate Injections | 6 |
| A Saline Group A will serve as a control and will receive only injections of saline as a placebo. | 6 |
| B PhosphatidylcholineDeoxycholate/Saline Group B will receive saline injections on one side of the body and receive PhosphatidylcholineDeoxycholate injections on the contralateral side. | 6 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 6 | 6 | 6 |
Baseline characteristics
| Characteristic | Total | C Phosphatidylcholine Deoxycholate | A Saline | B PhosphatidylcholineDeoxycholate/Saline |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — | — | — |
| Age, Categorical >=65 years | 0 Participants | — | — | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — | — | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Efficacy of Phosphatidylcholine and Deoxycholate Subcutaneous Injections for Localized Fat Removal.
The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits
Time frame: 1 year
Population: PI left institution and no data is available.