Roflumilast Cream for Eczema

No longer recruiting at 22 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a cream called ARQ-151 (Roflumilast Cream) for infants with eczema, a condition causing itchy, inflamed skin. The cream will be applied once daily for four weeks. Children with mild to moderate eczema for at least one month and skin involvement covering 3% or more of their body are eligible to participate. The study aims to find better treatment options for managing eczema in young children. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to advance eczema care for infants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ARQ-151 cream 0.05% is likely to be safe for humans?

Research has shown that roflumilast cream, a strong treatment for eczema, has been tested for safety and effectiveness. In past studies, patients using different strengths of the cream, including a 0.05% concentration, showed promising results. These studies found that the cream was generally well-tolerated, with few side effects.

The studies reported that any unwanted effects were usually mild and not a major concern. Common reactions included some irritation at the application site, but these were not serious and often resolved on their own. This suggests the cream is relatively safe, though individual experiences may differ.

The current trial is in an early stage and aims to confirm these safety findings in infants with eczema. While more data is always helpful, existing studies provide a positive view of the cream's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Roflumilast cream is unique because it targets a specific enzyme called phosphodiesterase-4 (PDE-4), offering a novel approach for treating eczema. Unlike traditional treatments like topical corticosteroids and calcineurin inhibitors, roflumilast reduces inflammation without the same risk of side effects like skin thinning or burning sensations. Researchers are excited about this treatment because it promises effective relief with potentially fewer side effects, making it a promising option for people with sensitive skin or those needing long-term management of eczema.

What evidence suggests that ARQ-151 cream might be an effective treatment for eczema?

Research has shown that ARQ-151 cream, containing roflumilast, may help treat eczema. One study found that this cream significantly reduced itching and improved sleep problems related to itching for patients. Another study found promising results for its effectiveness in adults with atopic dermatitis, another name for eczema. Roflumilast works by blocking a specific enzyme to reduce skin inflammation. These findings suggest that ARQ-151 could serve as an effective once-daily treatment for eczema. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/arcutis-atopic-dermatitis-cream/

First child enrolled in Arcutis' trial of atopic dermatitis cream

The INTEGUMENT-INFANT trial follows the outcomes from the ARQ-151-105 (MUSE) study, which also focused on assessing Zoryve 0.05% for AD in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9968264/

Patient-Reported Itch Outcomes of a Phase 2b Trial - PMC

In conclusion, in this Phase 2b study, once-daily roflumilast cream significantly improved itch and itch-related sleep loss in patients with ...

3.

arcutis.com

arcutis.com/arcutis-initiates-phase-3-clinical-trial-of-topical-roflumilast-cream-arq-151-as-a-potential-treatment-for-atopic-dermatitis-in-pediatric-patients-between-the-ages-of-two-and-five-years/

Arcutis Initiates Phase 3 Clinical Trial of Topical Roflumilast ...

In a previous Phase 2 trial, topical roflumilast has also shown encouraging efficacy in adult patients with atopic dermatitis. If approved, ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04845620

NCT04845620 | Trial of PDE4 Inhibition With Roflumilast ...

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

5.

journals.lww.com

journals.lww.com/jdpa/fulltext/2020/14030/the_safety_and_efficacy_of_roflumilast_cream_0_15_.27.aspx

The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05

This study suggests that roflumilast cream, a potent PDE-4 inhibitor, represents a potential effective once-daily treatment for AD.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06998056

NCT06998056 | Safety Study of Roflumilast Cream 0.05% ...

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).

7.

arcutis.com

arcutis.com/pipeline/topical-roflumilast-cream/

Topical Roflumilast Cream

Arcutis is investigating roflumilast cream 0.05% for the treatment of atopic dermatitis in children 3 to 24 months old. We have begun enrollment of the ...