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

Karo Pharma AB1 site in 1 country49 target enrollmentNovember 1, 2021

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hemorrhoids Grade I and II
Sponsor: Karo Pharma AB
Enrollment: 49
Locations: 1
Primary Endpoint: The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.
Status: Completed
Last Updated: 4 years ago

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

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

January 19, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Karo Pharma AB

Responsible Party

Sponsor

•Healthy subjects.
•Sex: male or female.
•Age: more than 18 years old.
•Symptomatic haemorrhoids stage 1 and 2 (Goligher classification).
•Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study.
•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).
•Able and willing to provide informed consent and comply with study procedures

•Pregnant or nursing woman or planning a pregnancy during the study.
•Subject not able or not willing to provide informed consent and comply with study procedures
•Subject who had been deprived of their freedom by administrative or legal decision.
•Major subject who is under guardianship or who is not able to express his consent.
•Subject in a social or sanitary establishment.
•Subject suspected to be non-compliant according to the Investigator's judgment. In terms of associated pathology
•Grade III or IV haemorrhoids (Goligher classification).
•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.
•Any anal surgery (including surgical or instrumental procedures in the last 60 days). Relating to previous or ongoing treatment
•Any anal topical medication applied in last 7 days.

The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.

Time Frame: 2 weeks

Severity of itch will be evaluated by the patient with a 6 point structured scale.

To evaluate the overall satisfaction of the patient according to(2 weeks)
To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,(2 weeks)
To evaluate by the patient the efficacy of tested product on the severity of bleeding(2 weeks)
To evaluate by the patient the efficacy of tested product on the sense of discomfort(2 weeks)