Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite
Primary Purpose
Cellulite, Body Contouring
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)
Sponsored by
About this trial
This is an interventional treatment trial for Cellulite
Eligibility Criteria
Inclusion Criteria:
- 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);
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures
Secondary Outcome Measures
Assessment of subject's satisfaction
Visual assessments of the treated area before and after treatment
Safety analysis
Full Information
NCT ID
NCT00399828
First Posted
November 14, 2006
Last Updated
March 11, 2008
Sponsor
Brazilan Center for Studies in Dermatology
1. Study Identification
Unique Protocol Identification Number
NCT00399828
Brief Title
Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite
Official Title
Clinical Study For Evaluation Of The Efficacy and Safety Of Tri-ActiveTM (Deka M.E.L.A., Itália) In Treatment Of Cellulite
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Brazilan Center for Studies in Dermatology
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite, Body Contouring
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)
Primary Outcome Measure Information:
Title
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures
Secondary Outcome Measure Information:
Title
Assessment of subject's satisfaction
Title
Visual assessments of the treated area before and after treatment
Title
Safety analysis
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:
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);
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.
Exclusion Criteria:
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Hexsel
Organizational Affiliation
Brazilian Center fpr Dermatological Studies
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite
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