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

March 19, 2018 updated by: The Cleveland Clinic

A Randomized, Double-Blinded, 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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C Phosphatidylcholine Deoxycholate
Phosphatidylcholine Deoxycholate Injections. Group C will receive only study drug injections
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
Other Names:
  • Lipodissolve
  • Lipolight
Placebo Comparator: A Saline
Group A will serve as a control and will receive only injections of saline as a placebo.
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
Other Names:
  • salt solution
Active Comparator: 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 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
Other Names:
  • Lipodissolve
  • Lipolight
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
Other Names:
  • salt solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Phosphatidylcholine and Deoxycholate Subcutaneous Injections for Localized Fat Removal.
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CCF2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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