Back to search results

Observational Study: Ruxolitinib Cream vs. Topical Corticosteroids in Pregnant Women with Atopic Dermatitis

This study is looking at the safety of Ruxolitinib Cream and topical corticosteroids (TCS) for women with atopic dermatitis (eczema) during pregnancy. Researchers will compare the number of major birth defects in babies born to women who used Ruxolitinib Cream during pregnancy versus those who used TCS. This is an observational study, meaning researchers will look at existing medical records rather than asking you to take a new treatment. Women aged 14 and older who were pregnant after September 21, 2021, and used either Ruxolitinib Cream or a TCS for their eczema are eligible. The study aims to see if there's a difference in birth defects up to 12 months after birth. The current status of this study is unclear.

Study design
This is an observational study looking at existing medical records of approximately 5621 women. It compares outcomes for women who used Ruxolitinib Cream to those who used topical corticosteroids.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Babies will be followed for major congenital malformations (birth defects) up to 12 months after birth.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06627335

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

Recruiting
Not specifiedAges 14+Observational
Incyte Corporation
~5,621 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:Ruxolitinib CreamTCS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of major congenital malformation (MCM)s
Measured over Up to 12 months after birth

Conditions

Pregnancy Related
Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

What this trial measures

  • Number of major congenital malformation (MCM)sUp to 12 months after birth

    Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age.