Thigh Cellulite Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment