Safety and Efficacy of a Dietary Supplement in Females With Cellulite

Study Overview
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Brief Summary
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To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.

Detailed Description
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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.

Official Title
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Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)

Conditions
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Cellulite (Orange Peel Skin)

Intervention / Treatment
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* Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)
* Dietary Supplement: Viatmin E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Menopause and pre-menopause Smoking 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dietary supplement for cellulite<br>PUFA, resveratrol, lycopene, beta carotene, lutein | Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)<br>* oral, twice daily in morning and evening for 6 months<br>|
| Active Comparator: Control<br>Vitamin E | Dietary Supplement: Viatmin E<br>* oral, twice daily in morning and evening for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical biochemistry (hematology, blood chemistry, blood coagulation) | change in clinical biochemistry at 6 months vs baseline | 6 months | 
| vital signs | change in clinical examination at 6 months vs baseline | 6 months | 
| adverse events and tolerability | change in number of persons with adverse events at 6 months vs baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cellulite severity | change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements | Day 1, 7, 30, 60, 90, 120, 150, 180 | 
| Thigh circumference | Change in thigh circumferences below gluteus fold within repeated measurements, Change in thigh circumferences above the upper part of the knee within repeated measurements | Day 1, 7, 30, 60, 90, 120, 150, 180 | 
| Digital photography | Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1 | Day 1, Day 90, Day 180 | 
| Ultrasound sonography | Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1 | Day 1, Day 90 and Day 180 | 
| Magnetic resonance | change in adipose tissue Day 180 vs Day 1 | Day 1 and Day 180 | 
| satisfaction questionnaire | Improvement in patient satisfaction | Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 | 
| dermatology life quality index | Improvements in the parameters of quality of life | day 1, 30, 60, 90, 120, 150, 180 | 
| celluquol questionnaire | each question in repeated measurements | day 1, 30, 60, 90, 120, 150, 180 | 
| cutometry | change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1 | day 1, 90, 180 | 
| corneometry | change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1 | day 1, 90, 180 | 
| skin profilometry | change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1 | day 1, 90, 180 | 
| liquichip analysis | change in inflammatory markers day 180 vs day 1 | day 1, day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orange peel skin, cellulite