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

NCT01920841 | Withdrawn

• 1 other identifier: PBRC 2013-058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Keywords

lipolytic; herbal extracts; thigh girth; thigh smoothness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Adverse events

  4 weeks

Study Arms (2)

Left (A), Right (B)

EXPERIMENTAL

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

Left (B) Right (A)

EXPERIMENTAL

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

Interventions

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

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

Left (A), Right (B)

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

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

Left (B) Right (A)

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant or nursing

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Nerium Biotechnology Inc: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank L Greenway, M.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 12, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)