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New cream shows promise for soothing hemorrhoid pain

NCT ID NCT06944951

Symptom relief Sponsor: Biokosmes Srl Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested a medical device cream called PROCTOeze® PLUS in 50 adults with mild to moderate hemorrhoids (Grade I-II). Participants applied the cream at home for 14 days to see if it improved symptoms and quality of life. The study measured changes using a short health questionnaire and a doctor-rated severity score.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PROCTOeze® PLUS (hydrophilic emulsion cream)
What this could lead to
If it works, this cream could offer a safe, non-drug option for easing hemorrhoid symptoms and improving quality of life.
What could go wrong
This is a small, completed post-market study with only 50 participants and no comparison group, so results may not apply to everyone. The cream only treats symptoms, not the underlying condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Nov 2024

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Patients able to do self-administration at home of the MD, for 14 days, to treat symptoms of haemorrhoids and anal irritation. * Patient free from the following treatments for haemorrhoids for at least 4 weeks: laser treatments for haemorrhoids, steroidal or non-steroidal anti-inflammatory drugs, analgesics, any anti-haemorrhoidal treatment, anticoagulants, and antiplatelet agents. * Patients able to communicate adequately with the Investigator and understand the tral questionnaire. * Patients able to understand and who can provide valid informed consent to the trial. Exclusion Criteria: * Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Disease). * Frequent hemorraidal bleeding * Severe, uncontrolled hypertension, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula. * Patients with known sensitivity to the tested medical device or its components. * Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study. * Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

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Conditions

The condition(s) this trial relates to.

hemorrhoid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemorrhoidal disease

Contacts and locations

Locations

  • C.M.I. Sisu Lucia Cristina

    Craiova, Dolj, Romania

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