Cellulitis Clinical Trial
Official title:
Clinical Effects of the Radial Extracorporeal Shock Wave Therapy (rESWT) Using the EMS Swiss Dolorclast and the Power+ Handpiece for Local Treatment of Cellulite
Verified date | October 2013 |
Source | Concept-Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
Extracorporeal shock wave therapy (ESWT) has been successfully introduced into the treatment of cellulite over the last years. The purpose of this study is to test the following hypotheses: (i) cellulite can be efficiently and safely treated using the radial extracorporeal shock wave device, Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland); and (ii) the individual clinical outcome of cellulite treatment with ESWT can be predicted by means of the patient's individual cellulite grade at baseline, the patient's individual age, body mass index (BMI), weight, and/or height.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 59 Years |
Eligibility |
Inclusion Criteria: - Healthy women, < 60 years of age with cellulite grade 2-3 - Unchanged hormonal treatment for < 6 months - Commitment to the study and ability to follow the medical directions during the study - Signed "informed-consent" form Exclusion Criteria: - Previous surgery in the treated area (especially liposuction) - Medical and/or cosmetic treatment of cellulite ongoing or within the last three months - Infection and/or tumor diseases within the treatment area - Anticoagulation therapy and/or hemorrhagic disorders - Pregnancy - Significant weight fluctuations (caused by disease or diet) - Modified hormonal treatment - Drugs (corticosteroids, non-steroidal antiinflammatory drugs, etc.) - Vascular abnormalities - Previous treatment with ESWT/RSWT |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Concept Clinic | Geneva |
Lead Sponsor | Collaborator |
---|---|
Concept-Clinic |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cellulite grade of the patient | Cellulite grades were determined by clinical inspection of the patients' skin (documented by digital photography) as well as by contact thermography. Photographs of the patients were taken before the treatment cycle and at each follow-up, with standardized lighting settings and distance to the patient at each photo shoot. The patients were asked to fully contract the buttock muscles at each time a photograph was taken. This aimed to fully show and standardize the appearance of the cellulite and thus to avoid any 'softening effects' due to varying muscle tones, changing the visibility of the cellulite. Contact thermography was performed using a professional cellulite thermodetector that was applied directly on the skin of the treated areas. At each clinical control, patients submitted a detailed questionnaire with scores for treatment comfort, pain intensity, and satisfaction, while also indicating undesired effects such as bruising, etc.. |
Cellulite grade was determined before the treatment and 4 weeks after the completed treatment cycle (8 weeks after the completed treatment cycle in case of bilateral treatment). | Yes |
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