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Ozone treatment associated with lymphatic drainage for cellulite treatment

Ozone therapy associated with body lymphatic drainage for the treatment of gynoid lipodystrophy - O3 - ozone MLD - Manual lymphatic drainage O3 - ozone MLD - Manual lymphatic drainage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-46qtfc2
Enrollment
Unknown
Registered
2021-10-05
Start date
2021-08-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cellulite,edema

Interventions

Experimental group: 20 women who have cellulite in the buttocks and hamstring region will receive subcutaneous injections of ozone at a concentration of 10 micrograms/ml with injected volume at each p
D063926

Sponsors

Una Uberlândia
Lead Sponsor
Una Uberlândia
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. 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

MeasureTime frame
The secondary outcome is improved patient satisfaction, which will be determined through validated questionnaires. 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.

Countries

Brazil

Contacts

Public ContactSilene Ribeiro
silene@tonederm.com.br+55 54 999514735

Outcome results

None listed

Source: REBEC (via WHO ICTRP)