New eczema cream shows promise for infants in safety trial

NCT ID NCT06998056

Completed Symptom relief Sponsor: Arcutis Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

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.

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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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