Hemoclin Gel for the Treatment of Hemorrhoids

Karo Pharma

Status: Completed

Conditions: Hemorrhoids Grade I and II

Treatments: Device: Hemoclin Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05124379

21E1799/HC_001

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Hemoclin Gel

Other group

Treatment:

Device: Hemoclin Gel