Back to resultsEfficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
Primary Purpose
Lipolysis
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Resveratrol lipoic Acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lipolysis
Eligibility Criteria
Inclusion Criteria:
- healthy volunteers with BMI > 23
Exclusion Criteria:
- resveratrol or lipoic acid allergies
Sites / Locations
- Faculty of Medicine, Chulalongkorn University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Resveratrol lipoic Acid
Placebo
Arm Description
lipoic and resveratrol was loaded on the patch
normal saline was loaded on transdermal patch
Outcomes
Primary Outcome Measures
fat thickness measured
fat thickness measurement by ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT03062163
First Posted
February 13, 2017
Last Updated
February 20, 2017
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT03062163
Brief Title
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
Official Title
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
February 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers
Detailed Description
66 participants with overweight received a resveratrol and lipoic acid transdermal patch treatment. The treatment areas have been treated including left and right arms. Subjects were evaluated using standardized measurements of body weight and circumference of arms at baseline and 2 weeks follow-up visits. Evaluation of physician were also measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resveratrol lipoic Acid
Arm Type
Experimental
Arm Description
lipoic and resveratrol was loaded on the patch
Arm Title
Placebo
Arm Type
Experimental
Arm Description
normal saline was loaded on transdermal patch
Intervention Type
Other
Intervention Name(s)
Resveratrol lipoic Acid
Intervention Description
Transdermal patch loaded with resveratrol and lipoic acid
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Transdermal patch loaded with normal saline
Primary Outcome Measure Information:
Title
fat thickness measured
Description
fat thickness measurement by ultrasound
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers with BMI > 23
Exclusion Criteria:
resveratrol or lipoic acid allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amornpun Sereemaspun, MD., Ph.D
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
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