- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851747
A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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:
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCF2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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