Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream in Reducing the Appearance of Cellulite in Human Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- thigh cellulite appearance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
thigh cellulite appearance
时间窗: 16 weeks
Reduction of cellulite appearance, as assessed by photographs, self-assessment and clinician assessment.
次要结局
- Uper leg circumference and fat content(16 weeks)
- Presence/absence of adverse reactions(16 weeks)