Weight LossThighCreamNCT01920841
A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women
A study testing Cream A applied to left thigh and Cream B to right thigh and Cream B applied to left thigh and Cream A to right thigh in people with Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Cream A applied to left thigh and Cream B to right thigh and Cream B applied to left thigh and Cream A to right thigh
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who feel that their thighs are too large and the skin is insufficiently smooth.
Who cannot join
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Weight Loss
- Being tested
- Cream A applied to left thigh and Cream B to right thigh, Cream B applied to left thigh and Cream A to right thigh
- Keywords
- lipolytic, herbal extracts, thigh girth, thigh smoothness
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cream A applied to left thigh and Cream B to right thighOther
Half the participants will receive Cream A applied to the left thigh, and Cream B applied to the right thigh
Cream B applied to left thigh and Cream A to right thighOther
Half the participants will receive Cream B applied to the left thigh and Cream A applied to the right thigh
| Study group | Role | What they receive |
|---|---|---|
| Left (A), Right (B) | Experimental | Cream A applied to left thigh and Cream B to right thigh Receives: 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 Receives: Other: Cream B applied to left thigh and Cream A to right thigh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: Four weeks
Adverse events
Any adverse reaction to the creams will be assessed
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Study Design changed and will be resubmitted as a new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nerium Biotechnology Inc
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank L Greenway, M.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920841
- Sponsor's protocol ID
- PBRC 2013-058
- Acronym
- ThighCream
- Status last verified
- Dec 2015
- First submitted
- 8 Aug 2013
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded Comparison Trial of Two Topical Creams to Reduce Thigh Girth and to Smooth Thigh Skin in Women.
- ClinicalTrials.gov ID
- NCT01920841
- Acronym / sponsor ID
- ThighCream / PBRC 2013-058
- Conditions
- Weight Loss
- Keywords
- lipolytic, herbal extracts, thigh girth, thigh smoothness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Design changed and will be resubmitted as a new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Nerium Biotechnology Inc
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left (A), Right (B) | Experimental | Other: Cream A applied to left thigh and Cream B to right thighCream A applied to left thigh and Cream B to right thigh |
| Left (B) Right (A) | Experimental | Other: Cream B applied to left thigh and Cream A to right thighCream B applied to left thigh and Cream A to right thigh |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who feel that their thighs are too large and the skin is insufficiently smooth.
Key exclusion criteria (1 listed)
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cream A applied to left thigh and Cream B to right thighHalf the participants will receive Cream A applied to the left thigh, and Cream B applied to the right thigh | Other | Left (A), Right (B) |
| Cream B applied to left thigh and Cream A to right thighHalf the participants will receive Cream B applied to the left thigh and Cream A applied to the right thigh | Other | Left (B) Right (A) |
Primary outcome
Difference in girth of the two thighs from baseline over the course of the treatment period
Time frame: 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
2 secondary outcomes
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.
Time frame: Four weeks
Adverse events
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank L Greenway, M.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cream A applied to left thigh and Cream B to right thigh and Cream B applied to left thigh and Cream A to right thigh in people with Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in girth of the two thighs from baseline over the course of the treatment period (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.