Cellulite (Orange Peel Skin) Clinical Trial
Official title:
Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)
To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | CBED: Brazilian Center for Studies in dermatology | Porto Alegre | Rio Grande do Sul |
| Lead Sponsor | Collaborator |
|---|---|
| DSM Nutritional Products, Inc. |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical biochemistry (hematology, blood chemistry, blood coagulation) | change in clinical biochemistry at 6 months vs baseline | 6 months | Yes |
| Primary | vital signs | change in clinical examination at 6 months vs baseline | 6 months | Yes |
| Primary | adverse events and tolerability | change in number of persons with adverse events at 6 months vs baseline | 6 months | Yes |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Magnetic resonance | change in adipose tissue Day 180 vs Day 1 | Day 1 and Day 180 | No |
| Secondary | satisfaction questionnaire | Improvement in patient satisfaction | Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 | No |
| Secondary | dermatology life quality index | Improvements in the parameters of quality of life | day 1, 30, 60, 90, 120, 150, 180 | No |
| Secondary | celluquol questionnaire | each question in repeated measurements | day 1, 30, 60, 90, 120, 150, 180 | No |
| Secondary | 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 | No |
| Secondary | corneometry | change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1 | day 1, 90, 180 | No |
| Secondary | skin profilometry | change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1 | day 1, 90, 180 | No |
| Secondary | liquichip analysis | change in inflammatory markers day 180 vs day 1 | day 1, day 180 | No |