Roflumilast cream

DRUG4 trials

Sponsors

AstraZeneca, Arcutis Biotherapeutics, Inc., Dermatology Consulting Services, PLLC

Conditions

Atopic Dermatitis EczemaDermatitisPlaque PsoriasisRosacea

Phase 2

A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis

WithdrawnNCT00746434

AstraZenecaPlaque Psoriasis

Start: 2008-11-30End: 2009-09-30Updated: 2016-12-05

A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)

WithdrawnNCT00746382

AstraZenecaDermatitis

Start: 2008-11-30End: 2009-09-30Updated: 2016-12-01

Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

CompletedNCT05278624

Dermatology Consulting Services, PLLCRosacea

Start: 2022-04-15End: 2023-02-17Updated: 2023-05-31

Phase 3

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

CompletedNCT04773600

Arcutis Biotherapeutics, Inc.Atopic Dermatitis Eczema

Start: 2021-02-24End: 2022-09-29Updated: 2024-10-04

Related Papers

Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children

JAMA Dermatology2024-09-1841 citations

641 - Pooled efficacy, patient-reported outcomes, and safety of roflumilast cream 0.15% from the INTEGUMENT-1 and INTEGUMENT-2 phase 3 trials of adults and children with atopic dermatitis

British Journal of Dermatology2024-08-01

Roflumilast Cream 0.15% in Patients with Atopic Dermatitis: Individual Patient Response from the Pooled INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials

SKIN The Journal of Cutaneous Medicine2024-03-18

505 - Once-daily roflumilast cream 0.15% for atopic dermatitis: pooled results from INTEGUMENT-1/2 phase 3 trials

British Journal of Dermatology2024-02-012 citations

504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis

British Journal of Dermatology2024-02-01

Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis

SKIN The Journal of Cutaneous Medicine2024-01-16

390 Efficacy and safety of roflumilast cream 0.15% in adults and children aged ≥6 years with mild to moderate atopic dermatitis in two phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2)

British Journal of Dermatology2023-06-011 citations