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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Weight Loss
• Intervention / Treatment: 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

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 52 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four weeks
Adverse events	Any adverse reaction to the creams will be assessed	4 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Nerium Biotechnology Inc
• Investigators: Principal Investigator: Frank L Greenway, M.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 9, 2013
• First Posted (Estimate): August 12, 2013

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: lipolytic; herbal extracts; thigh girth; thigh smoothness
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: PBRC 2013-058