CellulitisNCT00636025
Cellulite and Magnetic Resonance Imaging
An observational study of Cellulitis, run by Doris Hexsel.
Trial summary
The purpose of this study is to compare the anatomy of subcutaneous structures in areas with and without cellulite on the buttocks of same subjects with a non invasive technique, Magnetic Resonance Imaging. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulitis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Dec 2010
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females patients with cellulite on the buttocks.
Who may be able to join
- Written Informed Consent;
- Subjects agreeing to take part of all procedures of the study, after being fully informed on the objectives and nature of the investigations;
- Healthy female subjects over 18 years;
- Subjects presenting cellulite on the buttocks;
- Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
- Female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method (3 months before the enrollment until the end of the study);
- Availability of the subject throughout the duration of the study (180 days);
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.
Who cannot join
- Pregnant women or women intending to become pregnant during the study (next 3 months);
- Subjects participating in other clinical trials;
- Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
About this study
Official title: Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging
The purpose of this study is to compare the anatomy of subcutaneous structures in areas with and without cellulite on the buttocks of same subjects with a non invasive technique, Magnetic Resonance Imaging.
Read the detailed description
A cross-sectional study was performed at a single center, in accordance with good clinical practice. Thirty women aged 18 to 50 were included in this study. An experienced dermatologist evaluated all of the subjects in a standing position, with relaxed gluteus muscles, using the CSS classification. An area with cellulite and another without cellulite on the contralateral buttock were selected. The area with cellulite had an evident depressed lesion, whereas the area without cellulite had no depressed or raised lesions, The selected cellulite depression was marked with a positive symbol using a skin marking pen.
- Conditions
- Cellulitis
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence and characteristics of the fibrous septa in areas with and without cellulite.
image from MRI
Measured: at baseline
Secondary outcomes (1)
The characteristics of the subcutaneous tissue in areas with and without cellulite.
image from MRI
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CellulitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doris Hexsel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Doris Hexsel, Hexsel Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636025
- Sponsor's protocol ID
- 02-CBED07-04
- Status last verified
- Feb 2015
- First submitted
- 11 Mar 2008
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00636025
- Acronym / sponsor ID
- 02-CBED07-04
- Conditions
- Cellulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Doris HexselUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Mar 2008 (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.
The purpose of this study is to compare the anatomy of subcutaneous structures in areas with and without cellulite on the buttocks of same subjects with a non invasive technique, Magnetic Resonance Imaging.
Detailed description
A cross-sectional study was performed at a single center, in accordance with good clinical practice. Thirty women aged 18 to 50 were included in this study. An experienced dermatologist evaluated all of the subjects in a standing position, with relaxed gluteus muscles, using the CSS classification. An area with cellulite and another without cellulite on the contralateral buttock were selected. The area with cellulite had an evident depressed lesion, whereas the area without cellulite had no depressed or raised lesions, The selected cellulite depression was marked with a positive symbol using a skin marking pen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females patients with cellulite on the buttocks.
Key inclusion criteria (8 listed)
- Written Informed Consent;
- Subjects agreeing to take part of all procedures of the study, after being fully informed on the objectives and nature of the investigations;
- Healthy female subjects over 18 years;
- Subjects presenting cellulite on the buttocks;
- Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
Key exclusion criteria (3 listed)
- Pregnant women or women intending to become pregnant during the study (next 3 months);
- Subjects participating in other clinical trials;
- Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence and characteristics of the fibrous septa in areas with and without cellulite.
Time frame: at baseline
image from MRI
1 secondary outcome
The characteristics of the subcutaneous tissue in areas with and without cellulite.
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cellulitis, run by Doris Hexsel.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The presence and characteristics of the fibrous septa in areas with and without cellulite. (time frame: at baseline). 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 26 Feb 2015.