Cellulite (Orange Peel Skin)
Conditions
Keywords
orange peel skin, cellulite
Brief summary
To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTdietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)
oral, twice daily in morning and evening for 6 months
DIETARY_SUPPLEMENTViatmin E
oral, twice daily in morning and evening for 6 months
Sponsors
DSM Nutritional Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical biochemistry (hematology, blood chemistry, blood coagulation) | 6 months | change in clinical biochemistry at 6 months vs baseline |
| vital signs | 6 months | change in clinical examination at 6 months vs baseline |
| adverse events and tolerability | 6 months | change in number of persons with adverse events at 6 months vs baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound sonography | Day 1, Day 90 and Day 180 | Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1 |
| Magnetic resonance | Day 1 and Day 180 | change in adipose tissue Day 180 vs Day 1 |
| satisfaction questionnaire | Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 | Improvement in patient satisfaction |
| dermatology life quality index | day 1, 30, 60, 90, 120, 150, 180 | Improvements in the parameters of quality of life |
| cellulite severity | Day 1, 7, 30, 60, 90, 120, 150, 180 | change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements |
| cutometry | day 1, 90, 180 | change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1 |
| corneometry | day 1, 90, 180 | change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1 |
| skin profilometry | day 1, 90, 180 | change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1 |
| liquichip analysis | day 1, day 180 | change in inflammatory markers day 180 vs day 1 |
| celluquol questionnaire | day 1, 30, 60, 90, 120, 150, 180 | each question in repeated measurements |
| Thigh circumference | Day 1, 7, 30, 60, 90, 120, 150, 180 | Change in thigh circumferences below gluteus fold within repeated measurements, Change in thigh circumferences above the upper part of the knee within repeated measurements |
| Digital photography | Day 1, Day 90, Day 180 | Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1 |
Countries
Brazil
Outcome results
None listed