Osteoarthritis
Conditions
Interventions
This is a single-blind clinical study to evaluate the safety and efficacy of viscosupplement Viscoflex. The product evaluated in this study is injectable viscous supplements for joints affected by ost
Sponsors
Vênus Medicina Física e Reabilitação S/C Ltda
Vênus Medicina Física e Reabilitação S/C Ltda
Eligibility
Age
40 Years to 59 Years
Inclusion criteria
Inclusion criteria: Age group from 40 to 59 years old (during the pandemic and not belonging to the risk group – see exclusion criteria); male and female genders; Fitzpatrick skin type: I to V; participants with osteoarthritis (knee, shoulder, trapezius regions, and metacarpal);intact skin in the test area
Exclusion criteria
Exclusion criteria: Skin disorders in the region of product application (joints);pregnant or breastfeeding women;history of hypersensitivity to hyaluronic acid;Immunodeficiency;tendency to form hypertrophic or keloid scars;continuous use of anticoagulants or acetyl salicylic acid;use of surfactants containing quaternary ammonium salts in dermatological preparations;venous or lymphatic stasis in the limb to be treated;signs of inflammation and/or infection in the joint to be treated;persons in any of the COVID-19 risk groups, that is, over 60, with diabetes, chronic cardiovascular, kidney or respiratory disorders, immunosuppressed or bearing any other conditions that the medical doctor deems as belonging to a risk group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected that the product will be considered safe 90 days after application due to the absence or low rate of adverse events and joint discomfort. It is also expected that the product features will be proven effective through the participants' perception. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactJones Pinto
Laboratório Imunno Importação e Exportação - EIRELI
Outcome results
None listed