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Completed

NCT Number: NCT05984641

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

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.

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Key information

Conditions

Hemorrhoid Pain Anus Diseases Cardiovascular Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Haemorrhoid Inflammation Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Tor Vergata Foundation (PTV)

Rome, 00133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CONAN® Proctological Cream

Device

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.

Primary outcomes

  1. Change in the symptom numerical rating scale

    Time frame: 30 days

    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.

Secondary outcomes

  1. Evaluation of potential adverse events and treatment compliance

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Omikron Italia S.r.l.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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