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Extracorporeal Shock Wave Treatment for Cellulite

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. K-U Schlaudraff, Concept-Clinic
ClinicalTrials.gov Identifier:
NCT01974115
First received: October 28, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose
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.

Condition Intervention
Cellulitis Device: Radial extracorporeal shock wave therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. K-U Schlaudraff, Concept-Clinic:

Primary Outcome Measures:
  • Cellulite grade of the patient [ Time Frame: 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). ]

    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..



Enrollment: 14
Study Start Date: December 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radial extracorporeal shock wave therapy
All patients were treated with radial extracorporeal shock waves using the Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland) and the Power+ handpiece with the 36-mm applicator. Patients were treated unilaterally with two weekly treatments for four weeks on a randomly selected leg (left or right), totaling eight treatments on the selected side. After the application of coupling gel, treatment was performed at 3.5 to 4 bar, with 15,000 impulses per session, and applied at 15 Hz. Impulses were applied homogeneously over the posterior thigh and buttock area. One patient was treated on both legs, with each leg considered an independent treatment.
Device: Radial extracorporeal shock wave therapy
All patients were treated with radial extracorporeal shock waves using the Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland) and the Power+ handpiece with the 36-mm applicator. Patients were treated unilaterally with two weekly treatments for four weeks on a randomly selected leg (left or right), totaling eight treatments on the selected side. After the application of coupling gel, treatment was performed at 3.5 to 4 bar, with 15,000 impulses per session, and applied at 15 Hz. Impulses were applied homogeneously over the posterior thigh and buttock area. One patient was treated on both legs, with each leg considered an independent treatment.
Other Name: Swiss Dolorclast

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974115

Locations
Switzerland
Concept Clinic
Geneva, Switzerland, 1205
Sponsors and Collaborators
Concept-Clinic
Investigators
Principal Investigator: Kai U Schlaudraff, Dr.med. Concept Clinic Geneva (Switzerland)
  More Information

Responsible Party: Dr. K-U Schlaudraff, Dr.med.; owner and medical director of Concept-Clinic, Concept-Clinic
ClinicalTrials.gov Identifier: NCT01974115     History of Changes
Other Study ID Numbers: ConceptClinic-1
Study First Received: October 28, 2013
Last Updated: October 28, 2013

Keywords provided by Dr. K-U Schlaudraff, Concept-Clinic:
Cellulite
Extracorporeal shock wave therapy
ESWT
Radial shock wave therapy
RSWT

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 21, 2017