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Eczema cream safety during pregnancy under scrutiny: new study compares ruxolitinib to steroids

NCT ID NCT06627335

Knowledge-focused Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will analyze health records of over 5,600 pregnant women with atopic dermatitis (eczema) to compare infant outcomes between those who used ruxolitinib cream (Opzelura) and those who used topical corticosteroid creams. Researchers will look at rates of major birth defects, small-for-gestational-age births, and other pregnancy outcomes. The goal is to better understand the safety of these treatments during pregnancy.

What this could mean

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

Active substance
Ruxolitinib cream (Opzelura) and topical corticosteroids
What this could lead to
If successful, this study could provide important safety information about using ruxolitinib cream during pregnancy for women with atopic dermatitis.
What could go wrong
This is an observational study using existing claims data, not a controlled trial. It can show associations but not prove cause and effect. Results may be limited by data accuracy and unmeasured factors.

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 5,621 people

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

Started

Mar 2023

Expected to finish

Aug 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

Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period.

Ages

14 years and older

Sex

Female participants only

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: * Women aged 14 years or older at pregnancy outcome. * Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021. * At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort). * A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception. * Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy. * For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias. Exclusion Criteria: • One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema pregnancy disorder Pruritus

As listed by the trial registrant

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

Atopic dermatitis Pregnancy related

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Syneos Health (remote site)

    RECRUITING

    Morrisville, North Carolina, 27560, United States

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