Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
Public ClinicalTrials.gov record NCT04156191. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open Label, Phase 1, Pharmacokinetics, Maximal Usage Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a research study where all subjects will receive study medication to understand how the body processes the study medication, and to determine the PK, safety and efficacy of ARQ-151 cream 0.15% or 0.05% in adolescent and pediatric subjects with mild to moderate AD. At entry, subjects in Cohorts 1-3 will have 1.5-35% Body Surface Area involvement (excluding the scalp, palms, soles) and mild or moderate atopic dermatitis (AD) based on vIGA-AD. Cohort 2 and Cohort 3 will be performed in parallel and may commence after results are available from ARQ-151-212, a Phase 2 study evaluating ARQ-151 cream 0.05% and 0.15% administered once a day for 4 weeks in adolescents and adults with mild to moderate AD affecting 1.5% to 35% BSA. For the maximal usage PK study (Cohorts 4-8), subjects will have BSA involvement (excluding the scalp, palms, soles) of ≥ 35% in subjects 3 months old to 11 years old (inclusive) or ≥25% in subjects 12 to \<17 years old with mild or moderate AD . Seven groups will be evaluated, including: * Cohort 1: ARQ-151 cream 0.15% in adolescents (12-17 years old; inclusive) * Cohort 2: ARQ-151 cream 0.15% in children 6-11 years old (inclusive) * Cohort 3: ARQ-151 cream 0.15% in children 2-5 years old (inclusive; will be performed in parallel with Cohort 2) * Cohort 4: ARQ-151 cream 0.15% in adolescents 12 to \<17 years old * Cohort 5: ARQ-151 cream 0.15% in children 6-11 years old (inclusive) * Cohort 6: ARQ-151 cream 0.15% in children 2-5 years old (inclusive) * Cohort 7: ARQ-151 cream 0.05% in children 2-5 years old (inclusive) * Cohort 8: ARQ-151 cream 0.05% in children 3 months old to less than 2 years old Subjects will apply ARQ-151 cream 0.15% or 0.05% once a day for 28 days to all AD affected areas and any newly appearing AD lesions that arise during the study, except on the scalp.
Study identification
- NCT ID
- NCT04156191
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 101 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 22, 2019
- Primary completion
- May 1, 2023
- Completion
- May 1, 2023
- Last update posted
- Jul 23, 2023
2019 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arcutis Clinical Site 07 | Birmingham | Alabama | 35244 | — |
| Arcutis Clinical Site 11 | Rancho Santa Margarita | California | 92688 | — |
| Arcutis Clinical Site 02 | Coral Gables | Florida | 33146 | — |
| Arcutis Clinical Site 05 | Hialeah | Florida | 33016 | — |
| Arcutis Clinical Site 13 | Miami | Florida | 33137 | — |
| Arcutis Clinical Site 01 | Mt. Pleasant | South Carolina | 29464 | — |
| Arcutis Clinical Site 06 | San Antonio | Texas | 78213 | — |
| Arcutis Clinical Site 03 | Orem | Utah | 84058 | — |
| Arcutis Clinical Site 10 | West Jordan | Utah | 84088 | — |
| Arcutis Clinical Site 12 | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04156191, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2023 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04156191 live on ClinicalTrials.gov.