Clinical trial NCT01562470: Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thigh Cellulite
Keywords: cellulite
reduction
cream
thighs
women
Lead sponsor: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Sponsor class: NETWORK
First posted: 2012-03-23
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: thigh cellulite appearance
timeFrame: 16 weeks
Secondary outcomes:
measure: Uper leg circumference and fat content
timeFrame: 16 weeks
measure: Presence/absence of adverse reactions
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasource Diagnostics Inc.
state: Ontario
Study officials:
affiliation: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
name: Steven Traplin, MD
role: STUDY_DIRECTOR
affiliation: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
name: Maggie Laidlaw, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: