safety and efficacy of a dietary supplement in females with cellulite

Conditions: Cellulite (Orange Peel Skin)

Summary: to investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.

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.

Eligibility criteria:
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.

Keywords: orange peel skin cellulite