Roflumilast Cream for Eczema

Overseen By Arcutis Medical Information Arcutis Biotherapeutics, Inc.

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Arcutis Biotherapeutics, Inc.

Disqualifiers: Serious medical condition, Unstable AD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for infants aged 3 months to less than 2 years who have been diagnosed with atopic dermatitis, also known as eczema. The key requirement is that they must be able to apply the cream once daily for four weeks.

Inclusion Criteria

Informed consent of a parent(s) or legal guardian(s), as required by local laws

In good health as judged by the Investigator

I am between 3 months and 2 years old.

Exclusion Criteria

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ARQ-151 cream 0.05% applied once daily for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ARQ-151 cream 0.05%

Trial Overview The study tests the safety of a cream called ARQ-151 at a concentration of 0.05%. Infants in the trial will use this cream on their skin once every day for a month to see how well they tolerate it.

Participant Groups

Group I: ARQ-151 roflumilast cream 0.05% (open label) Experimental Treatment 1 Intervention

This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks.

Who Is Running the Clinical Trial?

Arcutis Biotherapeutics, Inc.

Lead Sponsor

Trials

22

Recruited

7,600+