- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01562470
Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Guelph, Ontario, Canada, N1H1Y3
- Nutrasource Diagnostics Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: herbal-based cellulite cream
Trial subjects will apply the treatment cream to one thigh and placebo to the other thigh, by random allocation.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
thigh cellulite appearance
Time Frame: 16 weeks
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Reduction of cellulite appearance, as assessed by photographs, self-assessment and clinician assessment.
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uper leg circumference and fat content
Time Frame: 16 weeks
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Reduction of upper leg circumference as measured by cm tape measure, and reduction of fat content of upper leg as measured using fat calipers
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16 weeks
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Presence/absence of adverse reactions
Time Frame: 16 weeks
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Any incidence of an adverse event or events will be recorded in an Adverse Events Diary, and results collated and reported.
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16 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Steven Traplin, MD, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Principal Investigator: Maggie Laidlaw, Ph.D., Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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