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Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

NCT06631170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2025-09-02

No results posted yet for this study

Summary

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.

Conditions

  • Atopic Dermatitis (AD)

Interventions

DRUG

Roflumilast Cream 0.15%

Roflumilast cream 0.15% is applied once daily for 4 weeks

DRUG

Vehicle cream

Vehicle cream is applied once daily for 4 weeks

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2025-05-27
Completion
2025-07-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631170 on ClinicalTrials.gov