Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease

Hemorrhoid Pain Clinical Trial

Official title:

Efficacy and Safety of CONAN® Proctological Cream Formulation in the Topical Treatment of Haemorrhoidal Disease and Anal Fissures: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05984641
• Other study ID #: CONAN2019
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2023
• Source: Omikron Italia S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of haemorrhoidal disease and anal fissures.

Description:

Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its potential efficacy in reducing related symptoms.

Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them, 20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the untreated control group (Group B). At each scheduled visit, total symptoms were assessed and recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events reported by study subjects were also assessed and recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 70 years

• Hemorrhoidal pathology, anal fissures and anitis

• NRS score = 3 for at least one of the symptoms (burning, itching, feeling of heaviness, foreign body)

Exclusion Criteria:

• Known hypersensitivity to study products

• Proctitis

• Current therapy with other local treatments based on phlebotropes and/or anti-inflammatories

• Surgical treatments undergone less than a year after inclusion

• Pregnancy, breastfeeding

Related Conditions & MeSH terms

• Hemorrhoid Pain
• Hemorrhoids
• Inflammation

Intervention

Device:
• CONAN® Proctological Cream
The active treatment samples used for the duration of the study were allocated at the site involved and consisted in 30 g tubes with an endorectal applicator, identified by the batch number, expiry date and information on the study on dedicated labels. The treatment of patients randomized to Group A consisted in applying the local treatment (1 application 3 times/day) for 30 days. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.

Locations

Country	Name	City	State
Italy	Policlinico Tor Vergata Foundation (PTV)	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Omikron Italia S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the symptom numerical rating scale	The primary outcome was the change in the symptom numerical rating scale (NRS) score after one month (V3) of treatment compared to the baseline in the two groups.	30 days
Secondary	Evaluation of potential adverse events and treatment compliance	The safety of the treatment was investigated by recording and systemic and local adverse events such as systemic allergic reactions, skin sensitisation and discomfort, etc. Treatment compliance was evaluated through assessment by the investigator of the empty study treatment cream tubes returned by patients at the end of the study.	30 days