Status:
COMPLETED
Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Conditions:
Atopic Dermatitis (Eczema)
Eligibility:
All Genders
3-2 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2025
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06998056
Start Date
June 9 2025
End Date
December 4 2025
Last Update
December 10 2025
Active Locations (22)
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1
Arcutis Clinical Study Site 208
Birmingham, Alabama, United States, 35244
2
Arcutis Clinical Study Site 221
Bryant, Arkansas, United States, 72022
3
Arcutis Clinical Study Site 214
Fountain Valley, California, United States, 92708
4
Arcutis Clinical Study Site 209
Rancho Santa Margarita, California, United States, 92688