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

NCT00851747 | Terminated Results

• 1 other identifier: CCF2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (3)

C Phosphatidylcholine Deoxycholate

EXPERIMENTAL

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

Drug: Phosphatidylcholine Deoxycholate

A Saline

PLACEBO COMPARATOR

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

Drug: Saline

B PhosphatidylcholineDeoxycholate/Saline

ACTIVE COMPARATOR

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

Drug: Phosphatidylcholine Deoxycholate; Drug: Saline

Interventions

Phosphatidylcholine Deoxycholate 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

Also known as: Lipodissolve, Lipolight

B PhosphatidylcholineDeoxycholate/Saline; C Phosphatidylcholine Deoxycholate

Saline 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

Also known as: salt solution

A Saline; B PhosphatidylcholineDeoxycholate/Saline

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

PI left institution, no data available.

Results Point of Contact

• Title: Rebecca Tung, MD
• Organization: Loyola Medical Center

rtung@loyolamedical.org

(708) 216-4962

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 17, 2018
• Results First Posted: April 17, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)