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Safety and Efficacy of a Dietary Supplement in Females With Cellulite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321268
Recruitment Status : Terminated (sponsor stopped study due to recruitment problems)
First Posted : March 23, 2011
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

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

Condition or disease Intervention/treatment Phase
Cellulite (Orange Peel Skin) Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein) Dietary Supplement: Viatmin E Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Clinical biochemistry (hematology, blood chemistry, blood coagulation) [ Time Frame: 6 months ]
    change in clinical biochemistry at 6 months vs baseline

  2. vital signs [ Time Frame: 6 months ]
    change in clinical examination at 6 months vs baseline

  3. adverse events and tolerability [ Time Frame: 6 months ]
    change in number of persons with adverse events at 6 months vs baseline

Secondary Outcome Measures :
  1. cellulite severity [ Time Frame: 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

  2. Thigh circumference [ Time Frame: 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

  3. Digital photography [ Time Frame: Day 1, Day 90, Day 180 ]
    Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1

  4. Ultrasound sonography [ Time Frame: Day 1, Day 90 and Day 180 ]
    Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1

  5. Magnetic resonance [ Time Frame: Day 1 and Day 180 ]
    change in adipose tissue Day 180 vs Day 1

  6. satisfaction questionnaire [ Time Frame: Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 ]
    Improvement in patient satisfaction

  7. dermatology life quality index [ Time Frame: day 1, 30, 60, 90, 120, 150, 180 ]
    Improvements in the parameters of quality of life

  8. celluquol questionnaire [ Time Frame: day 1, 30, 60, 90, 120, 150, 180 ]
    each question in repeated measurements

  9. cutometry [ Time Frame: day 1, 90, 180 ]
    change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1

  10. corneometry [ Time Frame: day 1, 90, 180 ]
    change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1

  11. skin profilometry [ Time Frame: day 1, 90, 180 ]
    change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1

  12. liquichip analysis [ Time Frame: day 1, day 180 ]
    change in inflammatory markers day 180 vs day 1

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321268

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CBED: Brazilian Center for Studies in dermatology
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
DSM Nutritional Products, Inc.
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Principal Investigator: Doris M Hexsel, MD Brazilian Center for Studies in Dermatology (CBED)
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Responsible Party: DSM Nutritional Products, Inc. Identifier: NCT01321268    
Other Study ID Numbers: 2009-11-03-CEL
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: February 2012
Keywords provided by DSM Nutritional Products, Inc.:
orange peel skin
Additional relevant MeSH terms:
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Skin Manifestations
Beta Carotene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents
Radiation-Protective Agents
Growth Substances