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

Conditions

• Atopic Dermatitis Eczema

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast Cream — DRUG
  Roflumilast cream 0.15% for topical application
• Vehicle cream — DRUG
  Vehicle cream for topical application

Study Details

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). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.

Key Dates

Start date

Feb 24, 2021

Status verified

Sep 2024

Primary completion

Sep 29, 2022

Completion

Sep 29, 2022

Study Design

Enrollment

683 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Roflumilast Cream 0.15%
  Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks.
• Placebo Comparator: Vehicle Cream
  Participants apply 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 (44)

Find similar trials in Birmingham, AL

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