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New eczema cream shows promise for infants in safety trial

NCT ID NCT06998056

Symptom relief Sponsor: Arcutis Biotherapeutics, 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a cream called roflumilast (0.05%) applied once daily for 4 weeks in 101 infants aged 3 months to 2 years with mild-to-moderate eczema. The main goal was to see if the cream is safe and well-tolerated. Researchers tracked side effects, serious side effects, and skin reactions at the application site.

What this could mean

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

Active substance
roflumilast cream 0.05%
What this could lead to
If successful, this could provide a new topical treatment option for infant eczema that is safe and easy to use.
What could go wrong
This is an early-phase safety study with only 101 infants and no placebo comparison. It does not measure how well the cream works, only its safety. Side effects may still occur.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

101 people

The number who actually took part.

Started

Jun 2025

Finished

Dec 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

3 months to 2 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: 1. Informed consent of a parent(s) or legal guardian(s), as required by local laws. 2. Males and females, ages 3 months to \<2 years old at Day 1. 3. Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit. 4. Has AD involvement of ≥3% BSA at Day1. 5. In good health as judged by the Investigator 6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Exclusion Criteria: 1. Subjects with any serious medical condition, clinically significant vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator. 2. Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms. 3. Subjects previously treated with ARQ-151 4. Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study. 5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language. Subjects who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. 6. Subjects who are family members of the clinical study staff or sponsor.

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema

As listed by the trial registrant

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

Atopic dermatitis (eczema)

Contacts and locations

Locations

  • Arcutis Clinical Study Site 201

    Santo Domingo, 10306, Dominican Republic

  • Arcutis Clinical Study Site 202

    San Antonio, Texas, 78218, United States

  • Arcutis Clinical Study Site 203

    Winnipeg, Manitoba, R3J0S9, Canada

  • Arcutis Clinical Study Site 204

    Halifax, Nova Scotia, B3K 5R3, Canada

  • Arcutis Clinical Study Site 206

    Portland, Oregon, 97239, United States

  • Arcutis Clinical Study Site 207

    Coral Gables, Florida, 33146, United States

  • Arcutis Clinical Study Site 208

    Birmingham, Alabama, 35244, United States

  • Arcutis Clinical Study Site 209

    Rancho Santa Margarita, California, 92688, United States

  • Arcutis Clinical Study Site 210

    Bellaire, Texas, 77401, United States

  • Arcutis Clinical Study Site 211

    Portsmouth, New Hampshire, 03801, United States

  • Arcutis Clinical Study Site 212

    Minneapolis, Minnesota, 55112, United States

  • Arcutis Clinical Study Site 213

    Jacksonville, Florida, 32256, United States

  • Arcutis Clinical Study Site 214

    Fountain Valley, California, 92708, United States

  • Arcutis Clinical Study Site 216

    Waterloo, Ontario, N2J1C4, Canada

  • Arcutis Clinical Study Site 217

    Delray Beach, Florida, 33484, United States

  • Arcutis Clinical Study Site 219

    West Lafayette, Indiana, 47906, United States

  • Arcutis Clinical Study Site 220

    Mason, Ohio, 45040, United States

  • Arcutis Clinical Study Site 221

    Bryant, Arkansas, 72022, United States

  • Arcutis Clinical Study Site 222

    Summerville, South Carolina, 29486, United States

  • Arcutis Clinical Study Site 223

    Boise, Idaho, 83706, United States

  • Arcutis Clinical Study Site 224

    Fort Worth, Texas, 76244, United States

  • Arcutis Clinical Study Site 225

    Saskatoon, Saskatchewan, S7K2C1, Canada

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