Clinical efficacy of Viscoflex® Viscosupplements in Osteoarthrosis
- Conditions
- Osteoarthritis
- Registration Number
- RBR-5vtrng9
- Lead Sponsor
- aboratório Imunno Importação e Exportação - EIRELI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Number of participants selected: 50; Age range: 40 to 59 (in times of pandemic and not belonging to the risk group – see exclusion criteria);Sex: male and female;Phototype (Fitzpatrick): I to V;Participants with osteoarthritis (knee, shoulder, trapezius, or metacarpal regions);Intact skin in the test region;
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method o secondary outcomes are expected.