Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis
A Phase 3 Multicenter, Double-blind, Vehicle-controlled Brigding Study to Evaluate the Efficacy and Safety of Roflumilast Cream 0.15% (ZORYVE®) in the Treatment of Patients With Mild to Moderate Atopic Dermatitis
1 other identifier
interventional
354
1 country
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2024
Shorter than P25 for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Start
First participant enrolled
November 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2025
CompletedSeptember 2, 2025
August 1, 2025
6 months
September 30, 2024
August 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects with vIGA-AD success
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline
Baseline, week 4
Secondary Outcomes (6)
In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, percentage of subjects with vIGA-AD success
Baseline, week 4
Percentage of subjects with vIGA-AD of "clear" or "almost clear"
Baseline, week 4
In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS
Baseline, week 4
Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)
Baseline, week 4
Safety: treatment emergence adverse events
Up to 4 weeks
- +1 more secondary outcomes
Study Arms (2)
Roflumilast cream 0.15%
EXPERIMENTALActive comparator
Vehicle cream
PLACEBO COMPARATORPlacebo comparator
Interventions
Roflumilast cream 0.15% is applied once daily for 4 weeks
Eligibility Criteria
You may qualify if:
- Male or female subjects aged ≥ 6 years at screening.
- Diagnosed with atopic dermatitis (AD) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6\~17 years at screening.
- Have stable disease for the past 4 weeks prior to screening.
- Have mild or moderate AD at baseline.
- Have BSA affected by AD of 3%-20% at baseline.
- Women of childbearing potential (WOCBP) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. WOCBP must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose.
- Being in good health as judged by the Investigator.
- Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.
You may not qualify if:
- Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- Previous treatment with roflumilast cream.
- Use of systemic treatments that affect the efficacy assessment of AD 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.
- Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
- Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
- Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
- Subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
The Second affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Aerospace General Hospital
Beijing, Beijing Municipality, China
Beijing Children's Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Chongqing Medical University Affiliated Second Hospital
Chongqing, Chongqing Municipality, China
People's Hospital Affiliated to Chongqing Three Gorges Medical College
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The Second affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The Sixth People's Hospital of Dongguan
Dongguan, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Second affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Union Shenzhen Hospital
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
The Fifth People's Hospital of Hainan Province
Haikou, Hainan, China
Kunming Children's Hospital
Kunming, Hainan, China, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
TCM Hospital of Shi Jia Zhuang City
Shijiazhuang, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The Second Hospital affiliated to Henan University of Science and Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
Hunan Children's Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital
Changsha, Hunan, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, Jiangsu, China
J.Y Hospital of TCM
Wuxi, Jiangsu, China
People's hospital of Wuxi
Wuxi, Jiangsu, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
The Second affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Dalian Dermatology Hospital
Dalian, Liaoning, China, China
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning, China
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin, Liaoning, China
The First affiliated Hospital of Baotou College
Baotou, Neimenggu, China
Jinan Central Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Hiser Medical Center of Qingdao
Qingdao, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
The Second affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
The Second Hospital of Ningbo
Ningbo, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 8, 2024
Study Start
November 21, 2024
Primary Completion
May 27, 2025
Study Completion
July 13, 2025
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share