Ozone treatment associated with lymphatic drainage for cellulite treatment

Not Applicable

• Conditions: Cellulite,edema; D063926; D004487

• Registration Number: RBR-46qtfc2
• Lead Sponsor: na Uberlândia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-05
• Study Completion: 2021-11-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

The sample will be composed of patients of both genders aged between 18 and 70 years who present gynoid lipodystrophy and who consent to sign and date the consent form and are available to follow the protocol

Exclusion Criteria

Patients who do not consent to sign the consent form and/or show unwillingness to follow the research procedures, patients with a history of bleeding, pregnancy, hyperthyroidism, even compensated cardiac arrhythmia, severe cardiac instability, glucose-6-phosphate dehydrogenase deficiency will be excluded (favism), allergic and/or intolerant to ozone., thrombocytopenia, hemochromatosis, patients being treated with iron or copper

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a reduction in cellulite by at least 50% compared to placebo, which will be determined by evaluating the photographic and thermographic record before and after the intervention.<br>To assess the improvement or reduction of cellulite, the Fibro Edema Geloid Severity Scale will be used and photographic and thermographic records of the treated area will be performed. This evaluation will be done at the beginning and at the end of the treatment. The images will be evaluated by two independent operators, without one having access to the other's evaluation.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is improved patient satisfaction, which will be determined through validated questionnaires.<br>Participants will answer the adapted questionnaires: Patient Satisfaction Analysis, Segot-chicq et al. (2007) and the Global Aesthetic Improvement Scale (GAIS), Narins (2003), which is used to classify the response to treatments, allowing a comparative assessment at different times after the therapeutic intervention.