Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- vital signs
研究概览
简要总结
To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.
详细描述
The study will be conducted as a single centre, randomized, double-blind, controlled, parallel group study with healthy female volunteers, aged 18-45 years of age, with skin phototypes I to VI and a clinical diagnosis of cellulite on buttocks (at least score 6 at Cellulite Severity Scale (CSS)).
The study will take 24 weeks (6 months) per subject. There will be one previsit during the screening phase and 8 visits per subject during the treatment phase.
Safety and efficacy variables will be performed monthly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers
- •Age between 18 and 45 years at Day 01 of the study
- •Body mass index (BMI) from 18.5 -24.9
- •All Fitzpatrick skin types
- •CSS score of at least 6
- •Normal eating habits (no vegetarians or vegans)
- •Written informed consent
排除标准
- •Menopause and pre-menopause
- •Pregnant women or women intending to become pregnant during study
- •Lactation period
- •Any kind of dermatological conditions
- •Vegetarians or vegans
- •Any kind of hepatitis, including any alteration in transaminases
- •Use of illicit drugs
- •Other surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (>160/95 mm Hg at repeated measurements)
- •Existence of scars and/or pigmentation in measurement areas (thighs and buttocks), which can influence study measurements
- •Participation in any other clinical trial including blood sampling and/or administration or substances up to 30 days before Day 01 of this study
- •Any prior aesthetic surgery (Liposuction, Subcision®), 3 months before the study, that may interfere with results
- •Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study
- •Participation in any other non-invasive clinical trial up to 30 days before Day 01 of this study, including blood sampling
- •Recent blood or plasmapherese donation (less than 1 month prior to Day 01 of the study)
- •Under medical treatment for a skin disease in the past and/or present with a therapy, which may influence the results of the study (systemic steroids or antibiotics, local steroids or topical immunomodulators during the last 3 months
- •Use of sun beds or self-tanning products or sun exposure for one month before and during study
- •Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
- •Subjects intending to initiate any intensive sports
- •Every other condition that the investigator might consider to involve a risk for the study subject.
研究组 & 干预措施
dietary supplement for cellulite
PUFA, resveratrol, lycopene, beta carotene, lutein
干预措施: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein) (Dietary Supplement)
Control
Vitamin E
干预措施: Viatmin E (Dietary Supplement)
结局指标
主要结局
vital signs
时间窗: 6 months
change in clinical examination at 6 months vs baseline
Clinical biochemistry (hematology, blood chemistry, blood coagulation)
时间窗: 6 months
change in clinical biochemistry at 6 months vs baseline
adverse events and tolerability
时间窗: 6 months
change in number of persons with adverse events at 6 months vs baseline
次要结局
- corneometry(day 1, 90, 180)
- Digital photography(Day 1, Day 90, Day 180)
- satisfaction questionnaire(Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180)
- dermatology life quality index(day 1, 30, 60, 90, 120, 150, 180)
- cutometry(day 1, 90, 180)
- cellulite severity(Day 1, 7, 30, 60, 90, 120, 150, 180)
- Thigh circumference(Day 1, 7, 30, 60, 90, 120, 150, 180)
- Ultrasound sonography(Day 1, Day 90 and Day 180)
- Magnetic resonance(Day 1 and Day 180)
- celluquol questionnaire(day 1, 30, 60, 90, 120, 150, 180)
- skin profilometry(day 1, 90, 180)
- liquichip analysis(day 1, day 180)