Cellulite (Orange Peel Skin)NCT01321268
Safety and Efficacy of a Dietary Supplement in Females With Cellulite
A study testing dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein) and Viatmin E in people with Cellulite (Orange Peel Skin), run by dsm-firmenich Switzerland AG at 1 site in Brazil.
Trial summary
To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite (Orange Peel Skin)
- What is being tested?
- dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein) and Viatmin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
CBED: Brazilian Center for Studies in dermatology
Porto Alegre, Rio Grande do Sul
About this study
Official title: 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.
Read the 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.
- Conditions
- Cellulite (Orange Peel Skin)
- Being tested
- dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein), Viatmin E
- Keywords
- orange peel skin, cellulite
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)Dietary supplement
oral, twice daily in morning and evening for 6 months
Viatmin EDietary supplement
oral, twice daily in morning and evening for 6 months
| Study group | Role | What they receive |
|---|---|---|
| dietary supplement for cellulite | Experimental | PUFA, resveratrol, lycopene, beta carotene, lutein Receives: Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein) |
| Control | Active comparator | Vitamin E Receives: Dietary Supplement: Viatmin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical biochemistry (hematology, blood chemistry, blood coagulation)
change in clinical biochemistry at 6 months vs baseline
Measured: 6 months
vital signs
change in clinical examination at 6 months vs baseline
Measured: 6 months
adverse events and tolerability
change in number of persons with adverse events at 6 months vs baseline
Measured: 6 months
Secondary outcomes (12)
cellulite severity
change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements
Measured: 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
Measured: 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
Measured: Day 1, Day 90, Day 180
Ultrasound sonography
Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1
Measured: Day 1, Day 90 and Day 180
Magnetic resonance
change in adipose tissue Day 180 vs Day 1
Measured: Day 1 and Day 180
satisfaction questionnaire
Improvement in patient satisfaction
Measured: 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
Measured: day 1, 30, 60, 90, 120, 150, 180
celluquol questionnaire
each question in repeated measurements
Measured: 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
Measured: day 1, 90, 180
corneometry
change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1
Measured: day 1, 90, 180
skin profilometry
change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1
Measured: day 1, 90, 180
liquichip analysis
change in inflammatory markers day 180 vs day 1
Measured: day 1, day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: sponsor stopped study due to recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellulite (Orange Peel Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doris M Hexsel, MD, Principal investigator, Brazilian Center for Studies in Dermatology (CBED)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321268
- Sponsor's protocol ID
- 2009-11-03-CEL
- Status last verified
- Feb 2012
- First submitted
- 10 Mar 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)
- ClinicalTrials.gov ID
- NCT01321268
- Acronym / sponsor ID
- 2009-11-03-CEL
- Conditions
- Cellulite (Orange Peel Skin)
- Keywords
- orange peel skin, cellulite
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor stopped study due to recruitment problems
- Enrolment
- 8 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary supplement for cellulite | Experimental | Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)PUFA, resveratrol, lycopene, beta carotene, lutein |
| Control | Active comparator | Dietary Supplement: Viatmin EVitamin E |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- Menopause and pre-menopause
- Smoking
- Pregnant women or women intending to become pregnant during study
- Lactation period
- Any kind of dermatological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)oral, twice daily in morning and evening for 6 months | Dietary supplement | dietary supplement for cellulite |
| Viatmin Eoral, twice daily in morning and evening for 6 months | Dietary supplement | Control |
Primary outcome
Clinical biochemistry (hematology, blood chemistry, blood coagulation)
Time frame: 6 months
change in clinical biochemistry at 6 months vs baseline
vital signs
Time frame: 6 months
change in clinical examination at 6 months vs baseline
adverse events and tolerability
Time frame: 6 months
change in number of persons with adverse events at 6 months vs baseline
12 secondary outcomes
cellulite severity
Time frame: Day 1, 7, 30, 60, 90, 120, 150, 180
Thigh circumference
Time frame: Day 1, 7, 30, 60, 90, 120, 150, 180
Digital photography
Time frame: Day 1, Day 90, Day 180
Ultrasound sonography
Time frame: Day 1, Day 90 and Day 180
Magnetic resonance
Time frame: Day 1 and Day 180
satisfaction questionnaire
Time frame: Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180
dermatology life quality index
Time frame: day 1, 30, 60, 90, 120, 150, 180
celluquol questionnaire
Time frame: day 1, 30, 60, 90, 120, 150, 180
cutometry
Time frame: day 1, 90, 180
corneometry
Time frame: day 1, 90, 180
skin profilometry
Time frame: day 1, 90, 180
liquichip analysis
Time frame: day 1, day 180
Results and safety
The study was stopped early (reason given: sponsor stopped study due to recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris M Hexsel, MD principal investigator
Brazilian Center for Studies in Dermatology (CBED)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein) and Viatmin E in people with Cellulite (Orange Peel Skin), run by dsm-firmenich Switzerland AG at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sponsor stopped study due to recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical biochemistry (hematology, blood chemistry, blood coagulation) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.