Thigh CellulitePhase 1NCT01562470
Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream
A Phase 1 study testing Cellulite reduction cream in people with Thigh Cellulite, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
Trial summary
Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo. This will be a double-blind, placebo-controlled study involving subjects with distinctive cellulite appearance on both thighs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thigh Cellulite
- What is being tested?
- Cellulite reduction cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 1
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: >18 years
- Cellulite present equally on both thighs
- Willing to apply cream, as directed, for 16 weeks
- Willing to maintain habitual diet throughout the trial
- Willing to refrain from making any lifestyle changes during the life of the trial (exercise regimes, specific diets or cleanses)
- Will to refrain from making any changes to smoking habits during the study period
- Participant is in good health on the basis of medical history
- Participant understands the study procedures and provides informed consent (signed) to participate and authorizes the release of relevant protected health information to the study investigators
Who cannot join
- Use of medications known to influence cellulite appearance
- Any leg surgical visit scheduled during trial
- Known intolerance or sensitivity to any ingredients in the study product
- Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream in Reducing the Appearance of Cellulite in Human Subjects
Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo.
This will be a double-blind, placebo-controlled study involving subjects with distinctive cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo to the other, by random allocation, and cellulite appearance will be measured at week 0, 8 and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.
Read the detailed description
Twenty subjects will be recruited through advertisements in local newspapers. Eligible subjects will be asked to visit the lab, where they will sign an information/consent form and answer a series of questions to determine their eligibility. If eligible, each subject will be asked to have their upper leg cellulite photographed, and thigh circumference will be measured. They will be given two containers of cream, labelled R (for right thigh) and L (for left thigh) which have been pre-weighed in their containers, and they will be instructed on how to apply the cream. They will record their perception of the amount of cellulite on a weekly basis, and they will also record any adverse events. At the two and four-month time-points, they will return to the lab with their diaries and cream. The cream in its container will be weighed to ensure compliance, and the diaries will be examined and returned to the participants. Thighs will again be photographed and circumference measured. At the four-month visit, subjects will return any remaining product for weighing, as well as their diaries for analysis.
Photographs from each subject will be coded and cellulite marks assessed by arranging the photographs chronologically, i.e. timepoint 1, timepoint 2 and timepoint 3. They will also be assessed by a (blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area in the photographs. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.
- Conditions
- Thigh Cellulite
- Being tested
- Cellulite reduction cream
- Keywords
- cellulite, reduction, cream, thighs, women
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellulite reduction creamOther
1/8 tsp cellulite cream will be applied to the thigh twice daily - in the morning and at night, for a period of 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| herbal-based cellulite cream | Experimental | Trial subjects will apply the treatment cream to one thigh and placebo to the other thigh, by random allocation. Receives: Other: Cellulite reduction cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
thigh cellulite appearance
Reduction of cellulite appearance, as assessed by photographs, self-assessment and clinician assessment.
Measured: 16 weeks
Secondary outcomes (2)
Uper leg circumference and fat content
Reduction of upper leg circumference as measured by cm tape measure, and reduction of fat content of upper leg as measured using fat calipers
Measured: 16 weeks
Presence/absence of adverse reactions
Any incidence of an adverse event or events will be recorded in an Adverse Events Diary, and results collated and reported.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thigh CelluliteStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Steven Traplin, MD, Study director, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.Maggie Laidlaw, Ph.D., Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562470
- Sponsor's protocol ID
- 10-104-002
- Status last verified
- Mar 2012
- First submitted
- 16 Aug 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream in Reducing the Appearance of Cellulite in Human Subjects
- ClinicalTrials.gov ID
- NCT01562470
- Acronym / sponsor ID
- 10-104-002
- Conditions
- Thigh Cellulite
- Keywords
- cellulite, reduction, cream, thighs, women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.Research network
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Mar 2012 (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.
Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo.
This will be a double-blind, placebo-controlled study involving subjects with distinctive cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo to the other, by random allocation, and cellulite appearance will be measured at week 0, 8 and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.
Detailed description
Twenty subjects will be recruited through advertisements in local newspapers. Eligible subjects will be asked to visit the lab, where they will sign an information/consent form and answer a series of questions to determine their eligibility. If eligible, each subject will be asked to have their upper leg cellulite photographed, and thigh circumference will be measured. They will be given two containers of cream, labelled R (for right thigh) and L (for left thigh) which have been pre-weighed in their containers, and they will be instructed on how to apply the cream. They will record their perception of the amount of cellulite on a weekly basis, and they will also record any adverse events. At the two and four-month time-points, they will return to the lab with their diaries and cream. The cream in its container will be weighed to ensure compliance, and the diaries will be examined and returned to the participants. Thighs will again be photographed and circumference measured. At the four-month visit, subjects will return any remaining product for weighing, as well as their diaries for analysis.
Photographs from each subject will be coded and cellulite marks assessed by arranging the photographs chronologically, i.e. timepoint 1, timepoint 2 and timepoint 3. They will also be assessed by a (blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area in the photographs. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| herbal-based cellulite cream | Experimental | Other: Cellulite reduction creamTrial subjects will apply the treatment cream to one thigh and placebo to the other thigh, by random allocation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: >18 years
- Cellulite present equally on both thighs
- Willing to apply cream, as directed, for 16 weeks
- Willing to maintain habitual diet throughout the trial
- Willing to refrain from making any lifestyle changes during the life of the trial (exercise regimes, specific diets or cleanses)
Key exclusion criteria (5 listed)
- Use of medications known to influence cellulite appearance
- Any leg surgical visit scheduled during trial
- Known intolerance or sensitivity to any ingredients in the study product
- Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
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 |
|---|---|---|
| Cellulite reduction cream1/8 tsp cellulite cream will be applied to the thigh twice daily - in the morning and at night, for a period of 16 weeks. | Other | herbal-based cellulite cream |
Primary outcome
thigh cellulite appearance
Time frame: 16 weeks
Reduction of cellulite appearance, as assessed by photographs, self-assessment and clinician assessment.
2 secondary outcomes
Uper leg circumference and fat content
Time frame: 16 weeks
Presence/absence of adverse reactions
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
Related trials for Thigh Cellulite
Not yet recruiting
Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
Thigh Cellulite
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.
Steven Traplin, MD study director
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Maggie Laidlaw, Ph.D. principal investigator
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cellulite reduction cream in people with Thigh Cellulite, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 26 Mar 2012. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
thigh cellulite appearance (time frame: 16 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 26 Mar 2012.