NCT04714684

The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using Fitostimoline in addition to or without other topical devices available on the market. Three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.

Conditions

• Fissure in Ano

Interventions

Type	Name	Description
DEVICE	Fitostimoline proctogel	Medical device for topical use for the treatment of fissures
DEVICE	Fitostimoline proctogel + muscle relaxant	medical device for topical use for the treatment of fissures

Timeline

• Start date: 2021-02-10
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2021-01-19
• Last updated: 2021-01-19