A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal - Full Text View

Sponsor:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00851747

Purpose

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.

Condition	Intervention
Obesity	Drug: Subcutaneous Phosphatidylcholine and Deoxycholate Injections Drug: Saline

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Lecithin

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Subcutaneous Phosphatidylcholine and Deoxycholate Injections: Active Comparator Subcutaneous Phosphatidylcholine and Deoxycholate Injections	Drug: Subcutaneous Phosphatidylcholine and Deoxycholate 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 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
Saline: Active Comparator 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	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

Arms

Assigned Interventions

Subcutaneous Phosphatidylcholine and Deoxycholate Injections: Active Comparator

Subcutaneous Phosphatidylcholine and Deoxycholate Injections

Drug: Subcutaneous Phosphatidylcholine and Deoxycholate 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

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

Saline: Active Comparator

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

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

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851747

Locations

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

Sponsors and Collaborators

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic Department of Dermatology ( Edward Galiczynski, DO )
Study ID Numbers:	CCF2
Study First Received:	February 25, 2009
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00851747 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Therapeutic Uses
Cholagogues and Choleretics
Gastrointestinal Agents

Deoxycholic Acid
Nutrition Disorders
Overweight
Overnutrition
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010