CellulitePhase 4NCT00399828
Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite
A Phase 4 study testing TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália) in people with Cellulite and Body Contouring, run by Hexsel Dermatology Clinic.
Trial summary
The purpose of this study is to assess the efficacy of device TRI-ACTIVETM (DEKA M.E.L.A., Itália)in the treatment od cellulite and body contouring. 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, Body Contouring
- What is being tested?
- TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Nov 2006
- Phase
- Phase 4
- 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
- Written Informed Consent;
- Subjects agreeing to take part of all procedures of the study (including mechanical massage, photographs), after being fully informed on the objectives and nature of the investigations;
- Female subjects between 18-45 years;
- Subjects presenting with cellulite grades I-III on buttocks and thighs;
- 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 device 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 enrollement untill the end of the study);
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- Body Mass Index (BMI = weight/height2) beetwen 20,0-25,0;
- Availability of the subject throughout the duration of the study (60 days);
- Availability of the subject in maintaining a stable weight during the study (variation less than 2 kg)
- 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);
- BMI superior 25,0;
- Subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis;
- Subjects participating in other clinical trials;
- Subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolled hypertension;
- Subjects with coagulation disorders, using anticoagulants or tendency of bruises;
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- Subjects with vascular disorders (phlebitis or varicose veins) in the area to be treated;
- Any prior aesthetic surgery affecting the area to be treated (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;
- Subjects with inflammation or active infection in the area to be treated.
- Subjects with a history of adverse effects, which in the investigator's opinion should prevent the patient from participating in the study;
- Patients with cutaneous or vascular alterations, that difficult visualization and documentation of cellulite;
- Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol;
- Subjects who can not come to the visits (one missing visit/ month is allowed);
- Subjects intending to initiate any intensive sport;
- Subjects using analgesics, non-hormonal antiinflammatories, antihistaminics, corticosteroids, or diuretics;
- Subjects tanned, or intending to expose the area of study to sun, artificial UV, or self-tanning during the study;
- Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
About this study
Official title: Clinical Study For Evaluation Of The Efficacy and Safety Of Tri-ActiveTM (Deka M.E.L.A., Itália) In Treatment Of Cellulite
The purpose of this study is to assess the efficacy of device TRI-ACTIVETM (DEKA M.E.L.A., Itália)in the treatment od cellulite and body contouring.
Read the detailed description
The present study is a clinical, opened trial and single-center.
The patients will be treated by six laser diodes, localised cooling system and rhythmical intake massage device. Application of the massage will be performed for 8 weeks in a total of 16 treatment sessions: twice a week.
A set of photographs will be taken at visit 1 (baseline), visit 2 and 3 with standardized positions and lighting conditions.
- Conditions
- Cellulite, Body Contouring
- Being tested
- TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures
Secondary outcomes (3)
Assessment of subject's satisfaction
Visual assessments of the treated area before and after treatment
Safety analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startAug 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Doris Hexsel, Study director, Brazilian Center fpr Dermatological Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399828
- Sponsor's protocol ID
- 02CBED0602
- Status last verified
- Mar 2008
- First submitted
- 14 Nov 2006
- Last updated
- 12 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study For Evaluation Of The Efficacy and Safety Of Tri-ActiveTM (Deka M.E.L.A., Itália) In Treatment Of Cellulite
- ClinicalTrials.gov ID
- NCT00399828
- Acronym / sponsor ID
- 02CBED0602
- Conditions
- Cellulite, Body Contouring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Nov 2006
- First posted
- 15 Nov 2006 (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 assess the efficacy of device TRI-ACTIVETM (DEKA M.E.L.A., Itália)in the treatment od cellulite and body contouring.
Detailed description
The present study is a clinical, opened trial and single-center.
The patients will be treated by six laser diodes, localised cooling system and rhythmical intake massage device. Application of the massage will be performed for 8 weeks in a total of 16 treatment sessions: twice a week.
A set of photographs will be taken at visit 1 (baseline), visit 2 and 3 with standardized positions and lighting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Written Informed Consent;
- Subjects agreeing to take part of all procedures of the study (including mechanical massage, photographs), after being fully informed on the objectives and nature of the investigations;
- Female subjects between 18-45 years;
- Subjects presenting with cellulite grades I-III on buttocks and thighs;
- 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 device under investigation;
Key exclusion criteria (18 listed)
- Pregnant women or women intending to become pregnant during the study (next 3 months);
- BMI superior 25,0;
- Subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis;
- Subjects participating in other clinical trials;
- Subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolled hypertension;
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 |
|---|---|---|
| TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália) | Device | – |
Primary outcome
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures
3 secondary outcomes
Assessment of subject's satisfaction
Visual assessments of the treated area before and after treatment
Safety analysis
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2008.
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Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
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Cellulite
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 Hexsel study director
Brazilian Center fpr Dermatological Studies
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália) in people with Cellulite and Body Contouring, run by Hexsel Dermatology Clinic.
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 10 inclusion and 18 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 12 Mar 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures. 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 12 Mar 2008.