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

Launched by ARCUTIS BIOTHERAPEUTICS, INC. · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a cream called Roflumilast (0.05%) to see how safe it is for infants aged 3 months to less than 2 years who have atopic dermatitis, which is also known as eczema. The cream will be applied once a day for four weeks. The main goal is to find out if the cream is safe for young children with mild to moderate eczema, and the study is not currently recruiting participants.

To be eligible for this study, infants must be diagnosed with eczema for at least one month and have a certain amount of skin affected. Parents or guardians must be able to give their consent and should be reliable in following the study's rules. However, infants with serious health issues or those who need strong steroids to manage their eczema won't be able to participate. Families can expect close monitoring during the study, and it's important for parents to understand the process and communicate effectively with the research team.

Gender

ALL

Eligibility criteria

• 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.