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

NCT ID: NCT01920841

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Weight Loss

Keywords

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lipolytic herbal extracts thigh girth thigh smoothness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Left (A), Right (B)

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Half the participants will receive Cream A applied to the left thigh, and Cream B applied to the right thigh

Left (B) Right (A)

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Half the participants will receive Cream B applied to the left thigh and Cream A applied to the right thigh

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant or nursing
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nerium Biotechnology Inc

UNKNOWN

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank L Greenway, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 2013-058

Identifier Type: -

Identifier Source: org_study_id