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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Recruitment Status : Withdrawn (Study Design changed and will be resubmitted as a new study)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

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date December 18, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2013)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)		 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, neurium oleander, salicin, caffeine and green tea extract 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
  • 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.
  • Adverse events [ Time Frame: 4 weeks ]
    Any adverse reaction to the creams will be assessed
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2013)		 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 ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women
Official Title  ICMJE A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Left (A), Right (B)
    Cream A applied to left thigh and Cream B to right thigh
    Intervention: Other: Cream A applied to left thigh and Cream B to right thigh
  • Experimental: Left (B) Right (A)
    Cream B applied to left thigh and Cream A to right thigh
    Intervention: Other: Cream B applied to left thigh and Cream A to right thigh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 15, 2015)		 0
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2013)		 12
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 52 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920841
Other Study ID Numbers  ICMJE PBRC 2013-058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Frank Greenway, Pennington Biomedical Research Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pennington Biomedical Research Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Nerium Biotechnology Inc
Investigators  ICMJE
Principal Investigator: Frank L Greenway, M.D. Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP