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Eczema cream safety watch: 8,000 kids monitored for a decade

NCT ID NCT00568997

Knowledge-focused Sponsor: Bausch Health Americas, Inc. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows 8,000 children aged 2 to 17 with eczema who have used Elidel cream (pimecrolimus 1%). Over 10 years, researchers track how many develop cancer, especially lymphoma and thyroid cancer. The goal is to see if the cream raises cancer risk. No new treatment is given; this is a safety monitoring study.

What this could mean

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

Active substance
Pimecrolimus (Elidel cream 1%)
What this could lead to
If this study finds no increased cancer risk, it could reassure families and doctors that Elidel cream is safe for long-term use in children with eczema.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. The results may take many years and could still leave uncertainty about rare risks.

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.

Participants

About 8,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2005

Expected to finish

Jun 2028

An estimate. End dates often move.

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.

Who is studied

Children (ages 2-17 years)

Ages

2 to 17 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: * males and females * greater than or equal to 2 years and less than or equal to 17 years at enrollment * diagnosis of atopic dermatitis (confirmed by treating physician) * applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks Exclusion Criteria: * past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease * past or present use of oral immunosuppressive therapy

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

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

Atopic dermatitis

Contacts and locations

Locations

  • Registry

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.