Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite

NCT00399828 | Terminated Phase 4

• 1 other identifier: 02CBED0602
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cellulite; Body Contouring

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália) DEVICE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Doris Hexsel

  Brazilian Center fpr Dermatological Studies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2006
• First Posted: November 15, 2006
• Study Start: August 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 12, 2008

Record last verified: 2008-03