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

Primary Purpose

Hemorrhoid Pain, Haemorrhoid Inflammation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CONAN® Proctological Cream
Sponsored by
Omikron Italia S.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoid Pain focused on measuring Haemorrhoids; anal fissures; controlled clinical trial.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Policlinico Tor Vergata Foundation (PTV)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Active treatment CONAN® (Medical Device, Omikron Italia Srl) a proctological cream containing 2.5% glycerin macerate from horse chestnut buds (escin), 1% hesperidin, 0.1% hyaluronic acid, 0.1% centella asiatica and 2.5% glycerinic extract of mallow; Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.

No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety 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.

Full Information

First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
Omikron Italia S.r.l.
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1. Study Identification

Unique Protocol Identification Number
NCT05984641
Brief Title
Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omikron Italia S.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoid Pain, Haemorrhoid Inflammation
Keywords
Haemorrhoids; anal fissures; controlled clinical trial.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study population was randomized into two treatment arms: Group A, active treatment (CONAN® Proctological Cream, Medical Device, Omikron Italia Srl) and Group B, the control group (bowel-function regulation).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Active treatment CONAN® (Medical Device, Omikron Italia Srl) a proctological cream containing 2.5% glycerin macerate from horse chestnut buds (escin), 1% hesperidin, 0.1% hyaluronic acid, 0.1% centella asiatica and 2.5% glycerinic extract of mallow; Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
Intervention Type
Device
Intervention Name(s)
CONAN® Proctological Cream
Intervention Description
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 Outcome Measure Information:
Title
Change in the symptom numerical rating scale
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Safety and Treatment compliance
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriella Giarratano
Organizational Affiliation
Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Tor Vergata Foundation (PTV)
City
Rome
ZIP/Postal Code
00133
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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