Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Completed · Phase 2

Conditions studied: Atopic Dermatitis (Eczema)

In brief

This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Key facts

Study ID

NCT06998056

Run by

Arcutis Biotherapeutics, Inc.

People needed

101

Starts

2025-06-09

Expected to finish

2025-12-04

Last updated by the study team

2025-12-10

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent of a parent(s) or legal guardian(s), as required by local laws.
• Males and females, ages 3 months to <2 years old at Day 1.
• Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit.
• Has AD involvement of ≥3% BSA at Day1.
• In good health as judged by the Investigator
• 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.

You may not qualify if…

• 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.
• Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
• Subjects previously treated with ARQ-151
• Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study.
• 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.
• Subjects who are family members of the clinical study staff or sponsor.

Where it is running

• Arcutis Clinical Study Site 208 — Birmingham, Alabama, United States
• Arcutis Clinical Study Site 221 — Bryant, Arkansas, United States
• Arcutis Clinical Study Site 214 — Fountain Valley, California, United States
• Arcutis Clinical Study Site 209 — Rancho Santa Margarita, California, United States
• Arcutis Clinical Study Site 207 — Coral Gables, Florida, United States
• Arcutis Clinical Study Site 217 — Delray Beach, Florida, United States
• Arcutis Clinical Study Site 213 — Jacksonville, Florida, United States
• Arcutis Clinical Study Site 223 — Boise, Idaho, United States
• Arcutis Clinical Study Site 219 — West Lafayette, Indiana, United States
• Arcutis Clinical Study Site 212 — Minneapolis, Minnesota, United States
• Arcutis Clinical Study Site 211 — Portsmouth, New Hampshire, United States
• Arcutis Clinical Study Site 220 — Mason, Ohio, United States
• Arcutis Clinical Study Site 206 — Portland, Oregon, United States
• Arcutis Clinical Study Site 222 — Summerville, South Carolina, United States
• Arcutis Clinical Study Site 210 — Bellaire, Texas, United States
• Arcutis Clinical Study Site 224 — Fort Worth, Texas, United States
• Arcutis Clinical Study Site 202 — San Antonio, Texas, United States
• Arcutis Clinical Study Site 203 — Winnipeg, Manitoba, Canada
• Arcutis Clinical Study Site 204 — Halifax, Nova Scotia, Canada
• Arcutis Clinical Study Site 216 — Waterloo, Ontario, Canada
• Arcutis Clinical Study Site 225 — Saskatoon, Saskatchewan, Canada
• Arcutis Clinical Study Site 201 — Santo Domingo, Dominican Republic

Full record on ClinicalTrials.gov

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