Atopic Dermatitis (Eczema)
Conditions
Keywords
atopic dermatitis, eczema
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).
Interventions
ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema).
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm open label study.
Eligibility
Sex/Gender
ALL
Age
3 Months to 2 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, Dominican Republic, United States
Outcome results
None listed