NCT06137820

CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle

Randomized Placebo-controlled Multi-center Study of Efficacy and Safety of a CFA-based Topical Cream Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Pharmanutra S.p.a. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®

Detailed description

After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Cetilar® cream (about 5 g, twice per day) or placebo cream (about 5 g, twice per day).

Conditions

• Ankle Injury or Chronic Trauma to the Ankle

Interventions

Type	Name	Description
DEVICE	Cetilar® (topical cream)	Topical cream twice daily for 30 days. An average amount of 5 g per day.
DEVICE	Cetilar Placebo	Cetilar placebo cream matching to Cetilar®. Topical cream twice daily for 30 days. An average amount of 5 g per day

Timeline

• Start date: 2022-11-18
• Primary completion: 2023-08-19
• Completion: 2023-12-31
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

3 sites across 2 countries: Georgia, Italy