Clinical trials

Explore our ongoing and completed clinical trials below. 

MOA
Disease state
Investigational therapy
Phase
Status
Clinical trial Phase MOA Disease state Investigational therapy Associated publications

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Phase: 2 MOA: PDE4 inhibitor Disease state: Atopic dermatitis Investigational therapy: Roflumilast cream (ARQ-151) 0.05%

Topical roflumilast cream (ARQ-151) atopic dermatitis study in pediatric patients (INTEGUMENT-PED)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Atopic dermatitis Investigational therapy: Roflumilast cream (ARQ-151) 0.05% Associated publications: Efficacy and Safety of Once-Daily Roflumilast Cream 0.05%in Pediatric Patients Aged 2–5 Years With Mild-to-ModerateAtopic Dermatitis (INTEGUMENT-PED): A Phase3 Randomized Controlled Trial

Topical roflumilast foam (ARQ-154) phase 3 seborrheic dermatitis study (STRATUM)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Seborrheic dermatitis Investigational therapy: Roflumilast foam (ARQ-154) Associated publications: Roflumilast Foam 0.3% For Adolescent and Adult Patients With Seborrheic Dermatitis: A Randomized, Double-Blinded, Vehicle-Controlled, Phase 3 Trial

Topical roflumilast foam (ARQ-154) phase 3 scalp and body psoriasis study (ARRECTOR)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Scalp and body psoriasis Investigational therapy: Roflumilast foam (ARQ-154) Associated publications: Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body The ARRECTOR Phase 3 Randomized Clinical Trial

Topical roflumilast foam (ARQ-154) phase 2b scalp and body psoriasis study

Completed

Phase: 2b MOA: PDE4 inhibitor Disease state: Scalp and body psoriasis Investigational therapy: Roflumilast foam (ARQ-154) Associated publications: Once-Daily Roflumilast Foam 0.3% For Scalp and Body Psoriasis: A Randomized, Double-Blind, Vehicle-Controlled Phase 2b Study

Topical roflumilast foam (ARQ-154) phase 2 seborrheic dermatitis phase 2 study

Completed

Phase: 2 MOA: PDE4 inhibitor Disease state: Seborrheic dermatitis Investigational therapy: Roflumilast foam (ARQ-154) Associated publications: Efficacy of Roflumilast Foam 0.3% In Patients With Seborrheic Dermatitis: A Double-Blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial

Topical roflumilast foam (ARQ-154) phase 2 seborrheic dermatitis long-term safety study

Completed

Phase: 2 MOA: PDE4 inhibitor Disease state: Seborrheic dermatitis Investigational therapy: Roflumilast foam (ARQ-154)

Topical roflumilast cream (ARQ-151) phase 3 plaque psoriasis study (DERMIS-2)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Plaque psoriasis Investigational therapy: Roflumilast cream (ARQ-151) 0.3% Associated publications: Effect of Roflumilast Cream Vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials

Topical roflumilast cream (ARQ-151) phase 3 plaque psoriasis study (DERMIS-1)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Plaque psoriasis Investigational therapy: Roflumilast cream (ARQ-151) 0.3% Associated publications: Effect of Roflumilast Cream Vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials

Topical roflumilast cream (ARQ-151) phase 3 plaque psoriasis open-label extension (DERMIS-OLE)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Plaque psoriasis Investigational therapy: Roflumilast cream (ARQ-151) 0.3%
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This website is intended for US healthcare professionals only. There may be information included that pertains to an investigational therapy or formulation that has not yet been approved for use in your country. The safety and efficacy of investigational therapies and/or formulations and/or uses have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated. This information is as of 10/2025 to the best of the Company’s knowledge and Arcutis assumes no obligation to update this information.

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