Clinical trial NCT01321268: Safety and Efficacy of a Dietary Supplement in Females With Cellulite
Official title: Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cellulite (Orange Peel Skin)
Keywords: orange peel skin
cellulite
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical biochemistry (hematology, blood chemistry, blood coagulation)
timeFrame: 6 months
measure: vital signs
timeFrame: 6 months
measure: adverse events and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: cellulite severity
timeFrame: Day 1, 7, 30, 60, 90, 120, 150, 180
measure: Thigh circumference
timeFrame: Day 1, 7, 30, 60, 90, 120, 150, 180
measure: Digital photography
timeFrame: Day 1, Day 90, Day 180
measure: Ultrasound sonography
timeFrame: Day 1, Day 90 and Day 180
measure: Magnetic resonance
timeFrame: Day 1 and Day 180
measure: satisfaction questionnaire
timeFrame: Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180
measure: dermatology life quality index
timeFrame: day 1, 30, 60, 90, 120, 150, 180
measure: celluquol questionnaire
timeFrame: day 1, 30, 60, 90, 120, 150, 180
measure: cutometry
timeFrame: day 1, 90, 180
measure: corneometry
timeFrame: day 1, 90, 180
measure: skin profilometry
timeFrame: day 1, 90, 180
measure: liquichip analysis
timeFrame: day 1, day 180
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: CBED: Brazilian Center for Studies in dermatology
state: Rio Grande do Sul
Study officials:
affiliation: Brazilian Center for Studies in Dermatology (CBED)
name: Doris M Hexsel, MD
role: PRINCIPAL_INVESTIGATOR
References: