Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

Conditions

• Atopic Dermatitis Eczema

Eligibility Criteria

Sex

ALL

Age

2 Years - 5 Years

Healthy Volunteers

Not accepted

Interventions

• Roflumilast Cream 0.05% — DRUG
  Roflumilast cream for topical application.
• Vehicle Cream — DRUG
  Vehicle cream matched to roflumilast cream for topical application.

Study Details

This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).

Key Dates

Start date

Apr 7, 2021

Status verified

Dec 2025

Primary completion

Jun 1, 2023

Completion

Jun 1, 2023

Study Design

Enrollment

652 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Roflumilast Cream 0.05%
  Participants applied roflumilast cream 0.05% qd for 4 weeks.
• Placebo Comparator: Vehicle Cream
  Participants applied vehicle cream qd for 4 weeks.

Primary Outcome Measure

Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 [ Time Frame: Week 4 ]

Locations (71)

Find similar trials in Birmingham, AL

Related Studies

• A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
  PHASE2 · Recruiting · Inmagene LLC · Lancaster, California
• Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD
  PHASE2 · Recruiting · Corvus Pharmaceuticals, Inc. · South San Francisco, California