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Full eligibility criteria for NCT01321268
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
Menopause and pre-menopause
Pregnant women or women intending to become pregnant during study
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.
All locations for NCT01321268
CBED: Brazilian Center for Studies in dermatology
Porto Alegre, Rio Grande do Sul, Brazil
View full eligibility
Tris trial is registered with FDA with number: NCT01321268. The sponsor of the trial is DSM Nutritional Products, Inc. and it is looking for 8 volunteers for the current phase.
Official trial title: Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)
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