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CompletedNCT00399854Updated Nov 15, 2006

Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring

A Phase 4 interventional study of Dhermia® - Industra Mecânica Fina Ltda in Cellulite and Body Contouring, sponsored by Brazilan Center for Studies in Dermatology. Completed. Open to female participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-11-15.

Sponsored by Brazilan Center for Studies in Dermatology · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Cellulite
  • Body Contouring

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03

In context

Cellulite

66 studies on the registry are indexed under Cellulite; 1 is open to participants now.

This study's enrollment of 45 is above the median of 37 across 60 interventional studies indexed under Cellulite.

Browse Cellulite studies →

Lead sponsor

Brazilan Center for Studies in Dermatology is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Written Informed Consent;
  2. 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;
  3. Female subjects between 25-45 years;
  4. Subjects presenting with cellulite grades I-III on buttocks and thighs;
  5. 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;
  6. 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);
  7. Body Mass Index (BMI = weight/height2) beetwen 20,0-25,0 and 25,0-29,9;
  8. Availability of the subject throughout the duration of the study (90 days);
  9. Availability of the subject in maintaining a stable weight during the study (variation less than 2 kg)
  10. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant women or women intending to become pregnant during the study (next 3 months);
  2. BMI superior 30,0;
  3. Subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis;
  4. Subjects participating in other clinical trials;
  5. Subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolled hypertension;
  6. Subjects with coagulation disorders, using anticoagulants or tendency of bruises;
  7. Subjects with vascular disorders (phlebitis or varicose veins) in the area to be treated;
  8. Any prior aesthetic surgery affecting the area to be treated (liposuction, Subcision®), 3 months before the study, that may interfere with results;
  9. Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study;
  10. Subjects with inflammation or active infection in the area to be treated.
  11. Subjects with a history of adverse effects, which in the investigator's opinion should prevent the patient from participating in the study;
  12. Patients with cutaneous or vascular alterations, that difficult visualization and documentation of cellulite;
  13. Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol;
  14. Subjects who can not come to the visits (one missing visit/ month is allowed);
  15. Subjects intending to initiate any intensive sport;
  16. Subjects using analgesics, non-hormonal antiinflammatories, antihistaminics, corticosteroids, or diuretics;
  17. Subjects tanned, or intending to expose the area of study to sun, artificial UV, or self-tanning during the study;
  18. Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants

Interventions

  • DeviceDhermia® - Industra Mecânica Fina Ltda
06

What researchers measure

Primary outcomes

  1. Assessment of effectiveness of treatment based on current classification of cellulite and evaluation of the corporal measures

Secondary outcomes

  1. Assessment of subject's satisfaction

  2. Visual assessments of the treated area before and after treatment

  3. Safety analysis

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00399854
Lead sponsor
Brazilan Center for Studies in Dermatology
First posted
Nov 15, 2006
Start date
Mar 2006
Completion
Jul 2006
Last update
Nov 15, 2006

Study contacts

Doris Hexsel, MD
study director · Brazilan Center for Studies in Dermatology
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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