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A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women (ThighCream)

Primary Purpose

Weight Loss

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cream A applied to left thigh and Cream B to right thigh
Cream B applied to left thigh and Cream A to right thigh
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring lipolytic, herbal extracts, thigh girth, thigh smoothness

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women who feel that their thighs are too large and the skin is insufficiently smooth.

Exclusion Criteria:

  • Pregnant or nursing

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Left (A), Right (B)

Left (B) Right (A)

Arm Description

Cream A applied to left thigh and Cream B to right thigh

Cream B applied to left thigh and Cream A to right thigh

Outcomes

Primary Outcome Measures

Difference in girth of the two thighs from baseline over the course of the treatment period
Creams with two different cream bases containing forskolin, nerium oleander, salicin,caffeine, and green tea extract that have been shown to be safe topically will be evaluated. Both cream bases will be applied to the thighs daily 5 days a week for 4 weeks, with each thigh receiving the same cream base everyday. The thighs will be measured weekly

Secondary Outcome Measures

Smoothness of the skin on the thighs treated with the two lipolytic creams differing in their bases compared to baseline using standardized photographs at baseline and at the end of the treatment.
The secondary endpoint will be assessed with standardized pictures of each thigh at baseline and on the last day of the fourth week which will end the study.
Adverse events
Any adverse reaction to the creams will be assessed

Full Information

First Posted
August 8, 2013
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
Collaborators
Nerium Biotechnology Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01920841
Brief Title
A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women
Acronym
ThighCream
Official Title
A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study Design changed and will be resubmitted as a new study
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Nerium Biotechnology Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate efficacy of two lipolytic creams differing in their bases and demonstrate that their herbal ingredients can reduce the size of the thigh and smooth the appearance of the thigh skin. It is hypothesized that creams with two different cream bases containing herbal products that stimulate the lipolytic process through stimulation of the beta-adrenergic receptor, with one cream base applied to each thigh daily 5 days a week for 4 weeks will reduce thigh girth and smooth the thigh skin compared to baseline.
Detailed Description
Participants will apply one cream (A) to one thigh and the second cream (B) to the other thigh under the supervision of a female clinic staff. The thigh to which each cream will be applied will be selected randomly, but half of the subjects will have cream A on the right thigh and cream B on the opposite thigh while the other half of the subjects will have the sides reversed. To evaluate the primary endpoint, both thighs will be measured at baseline and at the end of each treatment week, and the secondary endpoint will be assessed with standardized pictures of each thigh at baseline and on the last day of the fourth week which will end the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
lipolytic, herbal extracts, thigh girth, thigh smoothness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left (A), Right (B)
Arm Type
Experimental
Arm Description
Cream A applied to left thigh and Cream B to right thigh
Arm Title
Left (B) Right (A)
Arm Type
Experimental
Arm Description
Cream B applied to left thigh and Cream A to right thigh
Intervention Type
Other
Intervention Name(s)
Cream A applied to left thigh and Cream B to right thigh
Intervention Description
Half the participants will receive Cream A applied to the left thigh, and Cream B applied to the right thigh
Intervention Type
Other
Intervention Name(s)
Cream B applied to left thigh and Cream A to right thigh
Intervention Description
Half the participants will receive Cream B applied to the left thigh and Cream A applied to the right thigh
Primary Outcome Measure Information:
Title
Difference in girth of the two thighs from baseline over the course of the treatment period
Description
Creams with two different cream bases containing forskolin, nerium oleander, salicin,caffeine, and green tea extract that have been shown to be safe topically will be evaluated. Both cream bases will be applied to the thighs daily 5 days a week for 4 weeks, with each thigh receiving the same cream base everyday. The thighs will be measured weekly
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Smoothness of the skin on the thighs treated with the two lipolytic creams differing in their bases compared to baseline using standardized photographs at baseline and at the end of the treatment.
Description
The secondary endpoint will be assessed with standardized pictures of each thigh at baseline and on the last day of the fourth week which will end the study.
Time Frame
Four weeks
Title
Adverse events
Description
Any adverse reaction to the creams will be assessed
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women who feel that their thighs are too large and the skin is insufficiently smooth. Exclusion Criteria: Pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank L Greenway, M.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women

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