Atopic Dermatitis (Eczema)Phase 2NCT06998056
Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
A Phase 2 study testing ARQ-151 cream 0.05% in people with Atopic Dermatitis (Eczema), run by Arcutis Biotherapeutics, Inc. at 22 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 2 years
- Conditions the study is for
- Atopic Dermatitis (Eczema)
- What is being tested?
- ARQ-151 cream 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 9 Jun 2025to 4 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States17 sites
Arcutis Clinical Study Site 210
Bellaire, Texas, 77401
Arcutis Clinical Study Site 208
Birmingham, Alabama, 35244
Arcutis Clinical Study Site 223
Boise, Idaho, 83706
Arcutis Clinical Study Site 221
Bryant, Arkansas, 72022
Arcutis Clinical Study Site 207
Coral Gables, Florida, 33146
Arcutis Clinical Study Site 217
Delray Beach, Florida, 33484
Arcutis Clinical Study Site 224
Fort Worth, Texas, 76244
Arcutis Clinical Study Site 214
Fountain Valley, California, 92708
Arcutis Clinical Study Site 213
Jacksonville, Florida, 32256
Arcutis Clinical Study Site 220
Mason, Ohio, 45040
Arcutis Clinical Study Site 212
Minneapolis, Minnesota, 55112
Arcutis Clinical Study Site 206
Portland, Oregon, 97239
Arcutis Clinical Study Site 211
Portsmouth, New Hampshire, 03801
Arcutis Clinical Study Site 209
Rancho Santa Margarita, California, 92688
Arcutis Clinical Study Site 202
San Antonio, Texas, 78218
Arcutis Clinical Study Site 222
Summerville, South Carolina, 29486
Arcutis Clinical Study Site 219
West Lafayette, Indiana, 47906
Canada4 sites
Arcutis Clinical Study Site 204
Halifax, Nova Scotia, B3K 5R3
Arcutis Clinical Study Site 225
Saskatoon, Saskatchewan, S7K2C1
Arcutis Clinical Study Site 216
Waterloo, Ontario, N2J1C4
Arcutis Clinical Study Site 203
Winnipeg, Manitoba, R3J0S9
Dominican Republic1 site
Arcutis Clinical Study Site 201
Santo Domingo, 10306
About this study
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
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).
Read the 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).
- Conditions
- Atopic Dermatitis (Eczema)
- Being tested
- ARQ-151 cream 0.05%
- Keywords
- atopic dermatitis, eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-151 cream 0.05%Drug
ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema).
| Study group | Role | What they receive |
|---|---|---|
| ARQ-151 roflumilast cream 0.05% (open label) | Experimental | This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks. Receives: Drug: ARQ-151 cream 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of adverse events
Number of participants with adverse events during treatment will be assessed
Measured: 4 weeks
Subject incidence of serious adverse events
Number of participants with serious adverse events during treatment will be assessed
Measured: 4 weeks
Incidence of application site reactions
Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start9 Jun 2025
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (Eczema)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm open label study.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998056
- Sponsor's protocol ID
- ARQ-151-218
- Status last verified
- Dec 2025
- First submitted
- 5 May 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06998056
- Acronym / sponsor ID
- ARQ-151-218
- Conditions
- Atopic Dermatitis (Eczema)
- Keywords
- atopic dermatitis, eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm open label study.
| Arm | Type | Receives |
|---|---|---|
| ARQ-151 roflumilast cream 0.05% (open label) | Experimental | Drug: ARQ-151 cream 0.05%This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks. |
Who may qualify
- Ages
- 3 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARQ-151 cream 0.05%ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema). | Drug | ARQ-151 roflumilast cream 0.05% (open label) |
Primary outcome
Subject incidence of adverse events
Time frame: 4 weeks
Number of participants with adverse events during treatment will be assessed
Subject incidence of serious adverse events
Time frame: 4 weeks
Number of participants with serious adverse events during treatment will be assessed
Incidence of application site reactions
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ-151 cream 0.05% in people with Atopic Dermatitis (Eczema), run by Arcutis Biotherapeutics, Inc. at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject incidence of adverse events (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.