Clinical trial NCT06998056: Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
Official title: A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis (Eczema)
Keywords: atopic dermatitis
eczema
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm open label study.
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Subject incidence of adverse events
timeFrame: 4 weeks
measure: Subject incidence of serious adverse events
timeFrame: 4 weeks
measure: Incidence of application site reactions
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Arcutis Clinical Study Site 208
state: Alabama
city: Bryant
country: United States
facility: Arcutis Clinical Study Site 221
state: Arkansas
city: Rancho Santa Margarita
country: United States
facility: Arcutis Clinical Study Site 209
state: California
city: Coral Gables
country: United States
facility: Arcutis Clinical Study Site 207
state: Florida
city: Jacksonville
country: United States
facility: Arcutis Clinical Study Site 213
state: Florida
city: West Lafayette
country: United States
facility: Arcutis Clinical Study Site 219
state: Indiana
city: Minneapolis
country: United States
facility: Arcutis Clinical Study Site 212
state: Minnesota
city: Portsmouth
country: United States
facility: Arcutis Clinical Study Site 211
state: New Hampshire
city: Mason
country: United States
facility: Arcutis Clinical Study Site 220
state: Ohio
city: Fort Worth
country: United States
facility: Arcutis Clinical Study Site 224
state: Texas
city: Winnipeg
country: Canada
facility: Arcutis Clinical Study Site 203
state: Manitoba
city: Waterloo
country: Canada
facility: Arcutis Clinical Study Site 216
state: Ontario
city: Saskatoon
country: Canada
facility: Arcutis Clinical Study Site 225
state: Saskatchewan
Study officials:
References: