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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014