Safety and Efficacy of a Dietary Supplement in Females With Cellulite

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.

Study Overview

• Status: Terminated
• Conditions: Cellulite (Orange Peel Skin)
• Intervention / Treatment: Dietary supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein); Dietary supplement: Viatmin E

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • CBED: Brazilian Center for Studies in dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dietary supplement for cellulite; PUFA, resveratrol, lycopene, beta carotene, lutein	Dietary supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein); oral, twice daily in morning and evening for 6 months
Active Comparator: Control; Vitamin E	Dietary supplement: Viatmin E; oral, twice daily in morning and evening for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical biochemistry (hematology, blood chemistry, blood coagulation)	change in clinical biochemistry at 6 months vs baseline	6 months
vital signs	change in clinical examination at 6 months vs baseline	6 months
adverse events and tolerability	change in number of persons with adverse events at 6 months vs baseline	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Magnetic resonance	change in adipose tissue Day 180 vs Day 1	Day 1 and Day 180
satisfaction questionnaire	Improvement in patient satisfaction	Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180
dermatology life quality index	Improvements in the parameters of quality of life	day 1, 30, 60, 90, 120, 150, 180
celluquol questionnaire	each question in repeated measurements	day 1, 30, 60, 90, 120, 150, 180
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
corneometry	change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1	day 1, 90, 180
skin profilometry	change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1	day 1, 90, 180
liquichip analysis	change in inflammatory markers day 180 vs day 1	day 1, day 180

Collaborators and Investigators

• Sponsor: DSM Nutritional Products, Inc.
• Investigators: Principal Investigator: Doris M Hexsel, MD, Brazilian Center for Studies in Dermatology (CBED)

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: cellulite; orange peel skin
• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Platelet Aggregation Inhibitors; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Provitamins; Resveratrol; Beta Carotene; Carotenoids; Lycopene
• Other Study ID Numbers: 2009-11-03-CEL