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

Contrad Swiss

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: CR 500™ SINGLE-DOSE GEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05661162

CTD-SW CR500-KOA 2020

Details and patient eligibility

About

Single arm clinical investigation, post-market confirmatory interventional to assess performance, safety and tolerability of "CR500 SINGLE-DOSE GEL" medical device in patients with knee osteoarthritis (KOA).

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

CR500 single-dose gel

Other group

Description:

Interventional study on CR500 1.5 mL will be topically administered twice a week for four weeks

Treatment:

Device: CR 500™ SINGLE-DOSE GEL