Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Conditions

• Atopic Dermatitis Eczema

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast Cream 0.15% — DRUG
  Roflumilast Cream 0.15% - Active
• Vehicle Cream — DRUG
  Cream - Vehicle

Study Details

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

Key Dates

Start date

Jan 27, 2021

Status verified

Sep 2024

Primary completion

Aug 30, 2022

Completion

Aug 30, 2022

Study Design

Enrollment

654 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Roflumilast Cream 0.15%
  Participants with mild to moderate AD apply roflumilast cream 0.15% QD for 4 weeks.
• Placebo Comparator: Vehicle Cream
  Participants with mild to moderate AD 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 (42)

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