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

Phase 2

Recruiting

• Conditions: Atopic Dermatitis (Eczema)
• Interventions: Drug: ARQ-151 cream 0.05%

• Registration Number: NCT06998056
• Lead Sponsor: Arcutis Biotherapeutics, Inc.

Brief Summary

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).

Detailed Description

This study is an open label safety study in which ARQ-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Study Timeline

• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-28
• Study First Posted: 2025-05-31
• Status Verified: 2025-06
• Study Start: 2025-06-09
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARQ-151 roflumilast cream 0.05% (open label)	ARQ-151 cream 0.05%	This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Subject incidence of adverse events	4 weeks	Number of participants with adverse events during treatment will be assessed
Subject incidence of serious adverse events	4 weeks	Number of participants with serious adverse events during treatment will be assessed
Incidence of application site reactions	4 weeks	Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed

Trial Locations

Locations (13)

Arcutis Clinical Study Site 208; 🇺🇸 Birmingham, Alabama, United States

Arcutis Clinical Study Site 221; 🇺🇸 Bryant, Arkansas, 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 213; 🇺🇸 Jacksonville, Florida, 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 224; 🇺🇸 Fort Worth, Texas, United States

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