Hemoclin Gel for the Treatment of Hemorrhoids

Prospective, Open Clinical Investigation to Confirm the Effectiveness and Safety of Hemoclin Gel for the Treatment of Haemorrhoids.

Post market, single arm, clinical investigation to assess safety and performance of the product.

Study Overview

• Status: Completed
• Conditions: Hemorrhoids Grade I and II
• Intervention / Treatment: Device: Hemoclin Gel

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy subjects.
2. Sex: male or female.
3. Age: more than 18 years old.
4. Symptomatic haemorrhoids stage 1 and 2 (Goligher classification).
5. Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study.
6. Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day).
7. Able and willing to provide informed consent and comply with study procedures

Exclusion Criteria:

1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject not able or not willing to provide informed consent and comply with study procedures
3. Subject who had been deprived of their freedom by administrative or legal decision.
4. Major subject who is under guardianship or who is not able to express his consent.
5. Subject in a social or sanitary establishment.
6. Subject suspected to be non-compliant according to the Investigator's judgment. In terms of associated pathology
7. Grade III or IV haemorrhoids (Goligher classification).
8. Other pre-existing anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections.
9. Any anal surgery (including surgical or instrumental procedures in the last 60 days). Relating to previous or ongoing treatment
10. Any anal topical medication applied in last 7 days.
11. Known or suspected sensitivity or allergy to ingredients of the investigational product. In terms of COVID pandemic
12. Subject who was abroad in a country with higher incidence rate of Covid-19 than Poland within 14 days before the beginning of the study.
13. Subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal and above 37.5°C.
14. Subject who had contact with any person infected with COVID-19 within 10 days before the beginning of the study.
15. Subject who is currently during home quarantine recommended by the Sanitary Inspection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hemoclin Gel	Device: Hemoclin Gel; Non sterile gel for intra-rectal use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.	Severity of itch will be evaluated by the patient with a 6 point structured scale.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate by the patient the efficacy of tested product on the severity of bleeding	Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.	2 weeks
To evaluate by the patient the efficacy of tested product on the sense of discomfort	Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.	2 weeks
To evaluate the overall satisfaction of the patient according to	Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.	2 weeks
To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,	Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.	2 weeks

Collaborators and Investigators

• Sponsor: Karo Pharma AB

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 21E1799/HC_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No