Status:
TERMINATED
A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal
Lead Sponsor:
The Cleveland Clinic
Conditions:
Obesity
Eligibility:
FEMALE
25-70 years
Phase:
NA
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 w...
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 area...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00851747
Start Date
February 1 2009
End Date
October 1 2009
Last Update
April 17 2018
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195