Trials Sponsors Conditions Drugs Pricing

Conditions

Haemorrhoidal Disease

Keywords

haemorroidal diseasehaemorroidal crisisinternal haemorroidsexternal haemorroidsanal irritation

Outcome Measures

Primary Outcomes (1)

Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD)
The Short Health Scale for Haemorrhoidal Disease (SHSHD) will be used to evaluate the Quality of Life. The questionnaire will be completed by the patient at baseline and day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 7, where lower grades are better, with a total of 4 items on the scale (minimum score 4, maximum score 28). Is an instrument with just 1 question in each of its 4 dimensions, including symptom burden, functional status, disease-specific worries, and general well-being measured according to A 7-point Likert scale to be summed giving a total score ranging from 4 to 28. The total of the four dimensions has been analyzed. The unit of measure is "score". SHS was adapted for HD (Short Health Scale for Haemorrhoidal Disease - SHSHD) in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines; SHSHD has shown to be a reliable and responsive measure for HRQoL.
From enrollment to the end of treatment on day 14.

Secondary Outcomes (3)

Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician
From enrollment to the end of treatment on day 14.
Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient
From enrollment to the end of treatment on day 14.
Number of Treatment-emergent Adverse Events
From enrollment to the end of study on day 30.

Study Arms (1)

PROCTOeze® PLUS

EXPERIMENTAL

Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology.

Device: Hydrophilic emulsion for the relief of haemorroidal symptoms

Interventions

Hydrophilic emulsion for the relief of haemorroidal symptomsDevice

Administration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation.

PROCTOeze® PLUS

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men and women ≥ 18 years old.
Patients diagnosed with Grade I - II symptomatic haemorrhoids (according to Goligher classification) confirmed by clinical and anoscopic or proctoscopic examination performed within 3 months before baseline.

Sponsors & Collaborators

Biokosmes Srl
Industrylead

Study Sites (1)

C.M.I. Sisu Lucia Cristina

Craiova, Dolj, Romania

Limitations and Caveats

This study has no limitations since there are no drop-out patients and the symptoms measurements were performed with objective, widely-accepted and validated scales. In addition, treatment compliance was optimal according to the patient diary, which was filled in daily during the treatment period by all participants.

Results Point of Contact

Title: Donatella Mariani
Organization: Biokosmes Srl

Study Officials

Lucia Cristina Sisu, Dr.
CMI Dr Sisu Lucia Cristina
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

50 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 25, 2025

Study Start

November 5, 2024

Actual (reported)

Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

PROCTOeze® PLUS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

PROCTOeze® PLUS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations