Weight Loss
Conditions
Keywords
lipolytic, herbal extracts, thigh girth, thigh smoothness
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.
Interventions
OTHERCream 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
OTHERCream 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
Sponsors
Nerium Biotechnology Inc
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
Yes
Inclusion criteria
* Women who feel that their thighs are too large and the skin is insufficiently smooth.
Exclusion criteria
* Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed