Trials
Search / Trial NCT05661162

Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)

Launched by CONTRAD SWISS SA · Dec 13, 2022

Trial Information

Current as of January 21, 2025

Completed

Keywords

Knee Osteoarthritis; Hyaluronic Acid Peptides Synovial Fluid Algofunctional Scores Biochemical Markers Macrophages Infiltration

ClinConnect Summary

Subjects 26-83 years old will receive CR500 SINGLE-DOSE GEL given for the treatment of osteoarthritis of the knee over a 4-week time period. The primary objective of the study is to evaluate the effect of CR500 SINGLE-DOSE GEL in the treatment of KOA.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • 1. Male or Female, aged ≥18 years at the time of the signature of ICF (Informed Consent Form).
  • 2. Patients with a diagnosis of primary or secondary KOA affecting only one knee (monolateral KOA) of "mild" (score 1 - 4) or "moderate" (score 5 - 7) severity according to the LKI score.
  • 3. Willing to follow all study procedures, including attending all site visits, tests and examinations.
  • 4. Willing to participate in the study and sign the ICF.
  • Exclusion criteria
  • 1. Osteoarthritis (OA) in both knees (bilateral KOA).
  • 2. Other - different - clinical conditions of the knee.
  • 3. Infective or inflammatory processes near the area of treatment.
  • 4. Damaged skin in the area of treatment.
  • 5. Ongoing cutaneous allergies.
  • 6. Serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy.
  • 7. Allergy to device components (Sodium hyaluronate; Synthetic Human (SH)-Polypeptide-85; SH-Polypeptide-93; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; Polyethylene Glycol (PEG)-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).
  • 8. Any other systemic or local therapy for the treatment of KOA.
  • 9. Any other systemic or local therapy (e.g. NSAIDs, corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of KOA under treatment with the medical device CR500.
  • 10. Immune system illnesses.
  • 11. Uncontrolled systemic diseases.
  • 12. Known drug and/or alcohol abuse.
  • 13. Mental incapacity that precludes adequate understanding or cooperation.
  • 14. Participation in another investigational study.
  • 15. Pregnancy\* or breastfeeding.

About Contrad Swiss Sa

Contrad Swiss SA is a leading clinical trial sponsor specializing in the development and management of innovative healthcare solutions. With a strong commitment to advancing medical research, Contrad Swiss SA collaborates with a diverse range of stakeholders, including pharmaceutical companies, academic institutions, and healthcare providers, to facilitate the efficient execution of clinical trials. The organization is dedicated to maintaining the highest standards of compliance and ethical practices, ensuring patient safety and data integrity throughout the research process. Through its expertise in regulatory affairs and clinical operations, Contrad Swiss SA aims to accelerate the delivery of groundbreaking therapies to the market, ultimately improving patient outcomes and enhancing public health.

Locations

Castellanza, Varese, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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