Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT06631170
Phase
PHASE3
Status
Completed

Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast Cream 0.15% — DRUG
    Roflumilast cream 0.15% is applied once daily for 4 weeks
  • Vehicle cream — DRUG
    Vehicle cream is applied once daily for 4 weeks

Study Details

This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.

Key Dates

Start date
Nov 21, 2024
Status verified
Aug 2025
Primary completion
May 27, 2025
Completion
Jul 13, 2025

Study Design

Enrollment
354 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast cream 0.15%
    Active comparator
  • Placebo Comparator: Vehicle cream
    Placebo comparator

Primary Outcome Measure

Percentage of subjects with vIGA-AD success [ Time Frame: Baseline, week 4 ]

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