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Safety and Efficacy of a Dietary Supplement in Females With Cellulite

This study has been terminated.
(sponsor stopped study due to recruitment problems)
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier:
NCT01321268
First received: March 10, 2011
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention
Cellulite (Orange Peel Skin)
 Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)
Dietary Supplement: Viatmin E

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DSM Nutritional Products, Inc.:

Primary Outcome Measures:
  • Clinical biochemistry (hematology, blood chemistry, blood coagulation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    change in clinical biochemistry at 6 months vs baseline

  • vital signs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    change in clinical examination at 6 months vs baseline

  • adverse events and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    change in number of persons with adverse events at 6 months vs baseline


Secondary Outcome Measures:
  • cellulite severity [ Time Frame: Day 1, 7, 30, 60, 90, 120, 150, 180 ] [ Designated as safety issue: No ]
    change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements

  • Thigh circumference [ Time Frame: Day 1, 7, 30, 60, 90, 120, 150, 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, Day 90, Day 180 ] [ Designated as safety issue: No ]
    Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1

  • Ultrasound sonography [ Time Frame: Day 1, Day 90 and Day 180 ] [ Designated as safety issue: No ]
    Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1

  • Magnetic resonance [ Time Frame: Day 1 and Day 180 ] [ Designated as safety issue: No ]
    change in adipose tissue Day 180 vs Day 1

  • satisfaction questionnaire [ Time Frame: Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 ] [ Designated as safety issue: No ]
    Improvement in patient satisfaction

  • dermatology life quality index [ Time Frame: day 1, 30, 60, 90, 120, 150, 180 ] [ Designated as safety issue: No ]
    Improvements in the parameters of quality of life

  • celluquol questionnaire [ Time Frame: day 1, 30, 60, 90, 120, 150, 180 ] [ Designated as safety issue: No ]
    each question in repeated measurements

  • cutometry [ Time Frame: day 1, 90, 180 ] [ Designated as safety issue: No ]
    change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1

  • corneometry [ Time Frame: day 1, 90, 180 ] [ Designated as safety issue: No ]
    change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1

  • skin profilometry [ Time Frame: day 1, 90, 180 ] [ Designated as safety issue: No ]
    change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1

  • liquichip analysis [ Time Frame: day 1, day 180 ] [ Designated as safety issue: No ]
    change in inflammatory markers day 180 vs day 1


Enrollment: 8
Study Start Date: May 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321268

Locations
Brazil
CBED: Brazilian Center for Studies in dermatology
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Doris M Hexsel, MD Brazilian Center for Studies in Dermatology (CBED)
  More Information

No publications provided

Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT01321268     History of Changes
Other Study ID Numbers: 2009-11-03-CEL
Study First Received: March 10, 2011
Last Updated: February 24, 2012
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by DSM Nutritional Products, Inc.:
orange peel skin
cellulite

Additional relevant MeSH terms:
Carotenoids
Lycopene
Resveratrol
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
 Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013