Safety and Efficacy of a Dietary Supplement in Females With Cellulite

DSM Nutritional Products

Status

Terminated

Conditions

Cellulite (Orange Peel Skin)

Treatments

Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)

Dietary Supplement: Viatmin E

Study type

Interventional

Funder types

Industry

Identifiers

NCT01321268

2009-11-03-CEL

Details and patient eligibility

About

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

Full description

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.

Enrollment

8 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.