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

Not Applicable

Withdrawn

• Conditions: Weight Loss
• Interventions: Other: Cream B applied to left thigh and Cream A to right thigh; Other: Cream A applied to left thigh and Cream B to right thigh

• Registration Number: NCT01920841
• Lead Sponsor: Pennington Biomedical Research Center

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left (B) Right (A)	Cream B applied to left thigh and Cream A to right thigh	Cream B applied to left thigh and Cream A to right thigh
Left (A), Right (B)	Cream A applied to left thigh and Cream B to right thigh	Cream A applied to left thigh and Cream B to right thigh

Primary Outcome Measures

Name	Time	Method
Difference in girth of the two thighs from baseline over the course of the treatment period	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

Name	Time	Method
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.	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	4 weeks	Any adverse reaction to the creams will be assessed

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States