Back to resultsSafety and Efficacy of a Dietary Supplement in Females With Cellulite
Primary Purpose
Cellulite (Orange Peel Skin)
Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)
Viatmin E
Sponsored by
About this trial
This is an interventional treatment trial for Cellulite (Orange Peel Skin) focused on measuring orange peel skin, cellulite
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.
Sites / Locations
- CBED: Brazilian Center for Studies in dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dietary supplement for cellulite
Control
Arm Description
PUFA, resveratrol, lycopene, beta carotene, lutein
Vitamin E
Outcomes
Primary Outcome Measures
Clinical biochemistry (hematology, blood chemistry, blood coagulation)
change in clinical biochemistry at 6 months vs baseline
vital signs
change in clinical examination at 6 months vs baseline
adverse events and tolerability
change in number of persons with adverse events at 6 months vs baseline
Secondary Outcome Measures
cellulite severity
change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements
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
Digital photography
Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1
Ultrasound sonography
Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1
Magnetic resonance
change in adipose tissue Day 180 vs Day 1
satisfaction questionnaire
Improvement in patient satisfaction
dermatology life quality index
Improvements in the parameters of quality of life
celluquol questionnaire
each question in repeated measurements
cutometry
change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1
corneometry
change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1
skin profilometry
change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1
liquichip analysis
change in inflammatory markers day 180 vs day 1
Full Information
NCT ID
NCT01321268
First Posted
March 10, 2011
Last Updated
June 4, 2015
Sponsor
DSM Nutritional Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01321268
Brief Title
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
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
sponsor stopped study due to recruitment problems
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DSM Nutritional Products, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite (Orange Peel Skin)
Keywords
orange peel skin, cellulite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dietary supplement for cellulite
Arm Type
Experimental
Arm Description
PUFA, resveratrol, lycopene, beta carotene, lutein
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Vitamin E
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)
Intervention Description
oral, twice daily in morning and evening for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Viatmin E
Intervention Description
oral, twice daily in morning and evening for 6 months
Primary Outcome Measure Information:
Title
Clinical biochemistry (hematology, blood chemistry, blood coagulation)
Description
change in clinical biochemistry at 6 months vs baseline
Time Frame
6 months
Title
vital signs
Description
change in clinical examination at 6 months vs baseline
Time Frame
6 months
Title
adverse events and tolerability
Description
change in number of persons with adverse events at 6 months vs baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
cellulite severity
Description
change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements
Time Frame
Day 1, 7, 30, 60, 90, 120, 150, 180
Title
Thigh circumference
Description
Change in thigh circumferences below gluteus fold within repeated measurements, Change in thigh circumferences above the upper part of the knee within repeated measurements
Time Frame
Day 1, 7, 30, 60, 90, 120, 150, 180
Title
Digital photography
Description
Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1
Time Frame
Day 1, Day 90, Day 180
Title
Ultrasound sonography
Description
Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1
Time Frame
Day 1, Day 90 and Day 180
Title
Magnetic resonance
Description
change in adipose tissue Day 180 vs Day 1
Time Frame
Day 1 and Day 180
Title
satisfaction questionnaire
Description
Improvement in patient satisfaction
Time Frame
Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180
Title
dermatology life quality index
Description
Improvements in the parameters of quality of life
Time Frame
day 1, 30, 60, 90, 120, 150, 180
Title
celluquol questionnaire
Description
each question in repeated measurements
Time Frame
day 1, 30, 60, 90, 120, 150, 180
Title
cutometry
Description
change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1
Time Frame
day 1, 90, 180
Title
corneometry
Description
change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1
Time Frame
day 1, 90, 180
Title
skin profilometry
Description
change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1
Time Frame
day 1, 90, 180
Title
liquichip analysis
Description
change in inflammatory markers day 180 vs day 1
Time Frame
day 1, day 180
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris M Hexsel, MD
Organizational Affiliation
Brazilian Center for Studies in Dermatology (CBED)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CBED: Brazilian Center for Studies in dermatology
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
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Safety and Efficacy of a Dietary Supplement in Females With Cellulite
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