Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
NCT ID: NCT06998056
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2025-06-09
2025-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARQ-151 roflumilast cream 0.05% (open label)
This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks.
ARQ-151 cream 0.05%
ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema).
Interventions
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ARQ-151 cream 0.05%
ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema).
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Months
2 Years
ALL
No
Sponsors
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Arcutis Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Arcutis Clinical Study Site 208
Birmingham, Alabama, United States
Arcutis Clinical Study Site 221
Bryant, Arkansas, United States
Arcutis Clinical Study Site 214
Fountain Valley, California, 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 217
Delray Beach, Florida, United States
Arcutis Clinical Study Site 213
Jacksonville, Florida, United States
Arcutis Clinical Study Site 223
Boise, Idaho, 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 206
Portland, Oregon, United States
Arcutis Clinical Study Site 222
Summerville, South Carolina, United States
Arcutis Clinical Study Site 210
Bellaire, Texas, United States
Arcutis Clinical Study Site 224
Fort Worth, Texas, United States
Arcutis Clinical Study Site 202
San Antonio, Texas, United States
Arcutis Clinical Study Site 203
Winnipeg, Manitoba, Canada
Arcutis Clinical Study Site 204
Halifax, Nova Scotia, Canada
Arcutis Clinical Study Site 216
Waterloo, Ontario, Canada
Arcutis Clinical Study Site 225
Saskatoon, Saskatchewan, Canada
Arcutis Clinical Study Site 201
Santo Domingo, , Dominican Republic
Countries
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Other Identifiers
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ARQ-151-218
Identifier Type: -
Identifier Source: org_study_id
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