Effect of a Topical Cetylated Fatty Acid Cream on Pain Relief in Patients With Knee Osteoarthritis

NCT07745387 | Completed

• 1 other identifier: CETI-KNEE
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 4

Brief Summary

This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Cetilar® cream in adults with osteoarthritis-related knee pain. The study will assess the effects of treatment on knee pain, physical function, use of rescue medication, quality of life, and safety outcomes.

Conditions

Knee Osteoarthristis

Keywords

Knee Osteoarthritis; Knee Pain; Cetilar; Cetylated Fatty Acids; CFA

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Walking Arthritis Pain Intensity Score (VAS)

  Difference in mean change from baseline in walking arthritis pain intensity measured using a 100-mm Visual Analogue Scale (VAS).

  day 30

Secondary Outcomes (7)

• Change From Baseline in Walking Arthritis Pain Intensity Score (VAS)

  day 14

• Change From Baseline in Spontaneous Arthritis Pain Intensity Score (VAS)

  Days 14 and 30

• Change From Baseline in WOMAC Stiffness Score

  Days 14 and 30

• Change From Baseline in WOMAC Physical Function Score

  Days 14 and 30

• Change From Baseline in Lysholm Knee Scoring Scale (LKSS)

  Days 14 and 30

Other Outcomes (1)

• Change From Baseline in Quality of Life Assessed by SF-36

  day 30

Study Arms (2)

Cetilar® Cream

EXPERIMENTAL

Participants will receive Cetilar® cream containing cetylated fatty acids, applied topically to the affected knee twice daily (every 12±1 hours) for 30 days.

Other: Cetilar® Cream

Placebo Cream

PLACEBO COMPARATOR

Participants will receive matching placebo cream applied topically to the affected knee twice daily (every 12±1 hours) for 30 days.

Other: Placebo cream

Interventions

Cetilar® Cream OTHER

Topical cream containing cetylated fatty acids. The cream will be applied to the affected knee twice daily for 30 days.

Cetilar® Cream

Placebo cream OTHER

Matching placebo cream applied to the affected knee twice daily for 30 days.

Placebo Cream

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent.
• Male or female participants aged 40 to 75 years.
• Diagnosis of idiopathic knee osteoarthritis according to American College of Rheumatology (ACR) criteria.
• Compliance of the disease course with the following criteria:
• symptoms for at least 6 months prior to screening
• index knee pain for at least 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendinitis, etc.);
• walking arthritis pain required the periodic use of acetaminophen or NSAIDs (topical or oral products) on demand.
• Presence of X-ray (taken no more than 3 months before baseline) showing evidence of osteoarthritis with Kellgren-Lawrence grade 2-3 in the index knee.
• The average walking pain intensity during previous 24 hours in the index knee should be ≥40 mm on VAS (100 mm) at screening and prior to planned start of treatment.
• In case the patient uses helper (cane) during the walking, he/she should have been using it routinely during at least previous 6 months. The same helper should be used during the study.
• Patients who can use cream for 28-32 consecutive days (through the trial).
• Women of childbearing potential must agree to use an acceptable barrier method of contraception during study participation.

You may not qualify if:

• Intolerance or allergic reactions to any component of the study therapy. Severe hypersensitivity reactions to any drugs in past medical history.
• Usage of NSAIDs within 3 days or steroids within 7 days prior to planned start of treatment. In case when drug elimination exceeds defined period, it should be cancelled for the period of at least 5 half-lives.
• Usage of intra-articular hyaluronic acid injections for period less than 3 months prior to the planned start of treatment.
• Usage of DMOADs (disease-modifying osteoarthritis drugs) for period less than 3 months prior to the planned start of treatment.
• Open skin lesions or dermatological conditions at the site of cream application.
• Data on another etiology of the index knee joint lesion: gout, chondrocalcinosis, septic arthritis, infectious arthritis, Paget disease, aseptic osteonecrosis, seronegative spondyloarthropathies (psoriatic arthritis, ankylosing spondyloarthritis), metabolic (ochronosis, hemochromatosis) or autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus).
• Surgery or major trauma of the index knee within the previous 12 months.
• Presence of pain that could interfere with the assessment of knee pain (e.g. pain in any other part of the target lower extremity, pain radiating to the knee).
• BMI≥35 kg/m2.
• History of clinically relevant concomitant pathology at exacerbation or decompensation stage, specifically: verified heart failure (III-IV NYHA functional class), thrombosis, hemophilia and other coagulation disorders, decompensated diabetes mellitus type 2, uncontrollable seizures or any other pathology which, according to the investigator's opinion, prevents from the subject enrollment for safety reasons or may affect the study result.
• Liver damage (e.g. acute hepatitis, active chronic hepatitis, cirrhosis, hepatic encephalopathy) or hepatic enzyme levels (AST and/or ALT) \>2 UNL (upper normal level).
• History of expressed renal failure (creatinine clearance \< 30 mL/min) or blood creatinine and/or urea level \> 1,5 UNL (upper normal level).
• Uncontrollable hypertension: systolic blood pressure \> 180 mm Hg and/or diastolic blood pressure \> 110 mm Hg.
• Pregnant or breast-feeding women.
• Necessity to take any drugs and/or dietary supplements from the list of treatments prohibited by the protocol (see Section 7.6) during the period of the study.

Sponsors & Collaborators

• Pharmanutra S.p.a.: lead

Study Sites (4)

LLC "Altra Vita"

Tbilisi, Georgia

Location

LLC Institute of Clinical Cardiology

Tbilisi, Georgia

Location

LLC The First Medical Center

Tbilisi, Georgia

Location

LLC Unica

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: June 24, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

GE (4)