A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal

NCT ID: NCT00851747

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

C Phosphatidylcholine Deoxycholate

Phosphatidylcholine Deoxycholate Injections. Group C will receive only study drug injections

Group Type: EXPERIMENTAL

Phosphatidylcholine Deoxycholate

Intervention Type: DRUG

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

A Saline

Group A will serve as a control and will receive only injections of saline as a placebo.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

B PhosphatidylcholineDeoxycholate/Saline

Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side.

Group Type: ACTIVE_COMPARATOR

Phosphatidylcholine Deoxycholate

Intervention Type: DRUG

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

Saline

Intervention Type: DRUG

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

Interventions

Phosphatidylcholine 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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Other Intervention Names

Lipodissolve; Lipolight; salt solution

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CCF2

Identifier Type: -

Identifier Source: org_study_id