A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal
A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate 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 due to the known fat necrosis effects on fat tissue after study drug tissue
 incubation.
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.
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