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

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ClinicalTrials.gov Identifier: NCT01920841
Recruitment Status : Withdrawn (Study Design changed and will be resubmitted as a new study)
First Posted : August 12, 2013
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
Nerium Biotechnology Inc
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Loss Other: Cream A applied to left thigh and Cream B to right thigh Other: Cream B applied to left thigh and Cream A to right thigh Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women.
Study Start Date : June 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Left (A), Right (B)
Cream A applied to left thigh and Cream B to right thigh
 Other: Cream A applied to left thigh and Cream B to right thigh
Half the participants will receive Cream A applied to the left thigh, and Cream B applied to the right thigh
Experimental: Left (B) Right (A)
Cream B applied to left thigh and Cream A to right thigh
 Other: Cream B applied to left thigh and Cream A to right thigh
Half the participants will receive Cream B applied to the left thigh and Cream A applied to the right thigh


Outcome Measures
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Primary Outcome Measures :
  1. Difference in girth of the two thighs from baseline over the course of the treatment period [ Time Frame: Four weeks ]
    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 :
  1. 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. [ Time Frame: Four weeks ]
    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.

  2. Adverse events [ Time Frame: 4 weeks ]
    Any adverse reaction to the creams will be assessed


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or nursing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920841


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Nerium Biotechnology Inc
Investigators
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Principal Investigator: Frank L Greenway, M.D. Pennington Biomedical Research Center
More Information
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Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01920841    
Other Study ID Numbers: PBRC 2013-058
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
lipolytic
herbal extracts
thigh girth
thigh smoothness
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight