Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring
Primary Purpose
Cellulite, Body Contouring
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dhermia® - Industra Mecânica Fina Ltda
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 25-45 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 and 25,0-29,9;
- Availability of the subject throughout the duration of the study (90 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 30,0;
- 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 of the 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
NCT00399854
First Posted
November 14, 2006
Last Updated
November 14, 2006
Sponsor
Brazilan Center for Studies in Dermatology
1. Study Identification
Unique Protocol Identification Number
NCT00399854
Brief Title
Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring
Official Title
Clinical Study for Evaluation of the Efficacy of Mechanical Massage by Endermologie (Dhermia® - Industra Mecânica Fina Ltda) in Treatment of Cellulite and Body Contouring
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 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 perform a clinical assessment of the efficacy of the device DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring
Detailed Description
The present study is a clinical, opened trial and single-center.
The patients were treated by endermologie device. Mechanical massage were performed for 12 weeks in a total of 24 treatment sessions: twice a week.
A set of photographs were took at visit 1 (baseline), visit 2, 3 and 4 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
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Dhermia® - Industra Mecânica Fina Ltda
Primary Outcome Measure Information:
Title
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation of the 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
25 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 25-45 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 and 25,0-29,9;
Availability of the subject throughout the duration of the study (90 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 30,0;
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, MD
Organizational Affiliation
Brazilan Center for Studies in Dermatology
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring
We'll reach out to this number within 24 hrs