---
title: The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
nct_id: NCT04714684
overall_status: UNKNOWN
phase: NA
sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
study_type: INTERVENTIONAL
primary_condition: Fissure in Ano
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04714684.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04714684"
ct_last_update_post_date: 2021-01-19
last_seen_at: "2026-05-12T06:41:20.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

**NCT ID:** [NCT04714684](https://clinicaltrials.gov/study/NCT04714684)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- **Conditions:** Fissure in Ano
- **Start Date:** 2021-02-10
- **Completion Date:** 2022-02-10
- **CT.gov Last Update:** 2021-01-19

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* None previous therapies for anal fissure
* Symptomatic anal fistula
* Signing of informed consent
* age \>18 years old

Exclusion Criteria:

* Patients unable to complete the questionnaire and with a legal guardian.
* Patients with concomitant abscess/fistula
* Pregnant women
```

## Arms

- **fitostimoline proctogel** (EXPERIMENTAL)
- **fitostimoline proctogel + muscle relaxants** (EXPERIMENTAL)
- **muscle relaxants** (EXPERIMENTAL)

## Interventions

- **Fitostimoline proctogel** (DEVICE) — Medical device for topical use for the treatment of fissures
- **Fitostimoline proctogel + muscle relaxant** (DEVICE) — medical device for topical use for the treatment of fissures

## Primary Outcomes

- **control of anal fissure symptoms** _(time frame: 30 days)_ — pain relief (by using the NRS scale from 0 to 10 (0=absence of pain 10= maximum presence of pain) which should be lower than 3)
- **need of invasive treatment** _(time frame: 30 days)_ — Anal dilatation, lateral internal sphincterotomy

## Secondary Outcomes

- **anal fissure healing** _(time frame: 30 days)_

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04714684.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04714684*  
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