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New pill for Kids' eczema itch shows promise in large trial

NCT ID NCT01840605

Symptom relief Sponsor: Tanabe Pharma Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new oral medicine called TAU-284 (bepotastine besilate) can reduce itching in children aged 7 to 15 with atopic dermatitis (eczema). Over 300 children took either TAU-284 or an older medicine (ketotifen) twice daily for several weeks. The main goal was to see if TAU-284 works as well as ketotifen at easing itch severity.

What this could mean

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

Active substance
bepotastine besilate (TAU-284)
What this could lead to
If successful, this could provide a new oral option to reduce itching in children with eczema.
What could go wrong
This is a completed Phase 3 trial, but results may show it is no better than existing treatments. It only targets itching, not the underlying disease.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

303 people

The number who actually took part.

Start date

Mar 2013

Finished

Nov 2013

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

7 to 15 years

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: * Patients aged between 7 and 15 years * Patients giving assent and whose legal guardian giving informed consent * Outpatients * Patients diagnosed as atopic dermatitis * Patients who require the treatment with topical corticosteroid on areas other than face, head and neck * Patients whose diaries can be properly maintained * Patients who have 2 grades or more pruritus score Exclusion Criteria: * Patients with bronchial asthma who require concomitant use of the corticosteroid * Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy * Patients with current or previous history of drug hypersensitivity * Patients who have been treated with Bepotastine besilate in the past * Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied * Patients who have spastic disease such as epilepsy * Patients who concurrently have renal function abnormalities that may cause safety problems * Patients who do not give consent to use birth control * Pregnant patients, at risk of pregnancy or breastfeeding * Patients who had participated in any clinical trial in the last 12 weeks

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Conditions

The condition(s) this trial relates to.

atopic eczema atopic IgE-mediated allergic disorder dermatitis

As listed by the trial registrant

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

ATOPIC Dermatitis

Contacts and locations

Locations

  • Medical Corporation Kojinkai Asanuma Dermatology Clinic

    Hokkaido, Japan

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