Efficacy and Safety of Roflumilast Cream in Subjects with Atopic Dermatitis
- Conditions
- Atopic Dermatitis (AD)
- Interventions
- Drug: Vehicle cream
- Registration Number
- NCT06631170
- 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.
- Detailed Description
This is a parallel group, double blind, vehicle-controlled study in which Roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 351
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roflumilast cream 0.15% Roflumilast Cream 0.15% Active comparator Vehicle cream Vehicle cream Placebo comparator
- Primary Outcome Measures
Name Time Method Percentage of subjects with vIGA-AD success Baseline, week 4 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
- Secondary Outcome Measures
Name Time Method In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, percentage of subjects with vIGA-AD success Baseline, week 4 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).
Percentage of subjects with vIGA-AD of "clear" or "almost clear" Baseline, week 4 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).
In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS Baseline, week 4 The Worst Itch Numerical Rating Scale (WI-NRS) will be determined by the subject's recording of daily assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst itch imaginable" or "worst imaginable itch").
Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75) Baseline, week 4 EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). Four anatomic sites-head, upper extremities, trunk, and lower extremities-are assessed for erythema, induration/infiltration (papules), excoriation, and lichenification as seen on the day of the examination. To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Safety: treatment emergence adverse events Up to 4 weeks Incidence, severity, and causal relationship of treatment emergence adverse events (TEAE), TEAEs leading to withdrawal and death.
Trough concentration (Ctrough) Week 2, week 4 Trough concentration of plasma roflumilast and its N-oxide
Trial Locations
- Locations (61)
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
Chongqing Medical University Affiliated Second Hospital
🇨🇳Chongqing, Chongqing, China
People's Hospital Affiliated to Chongqing Three Gorges Medical College
🇨🇳Chongqing, Chongqing, 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
The Second affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Beijing Aerospace General Hospital
🇨🇳Beijing, Beijing, China
Beijing Children's Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, CMU
🇨🇳Beijing, Beijing, China
Liuzhou People's Hospital
🇨🇳Liuzhou, 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
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
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, China
Shanghai Children's Hospital
🇨🇳Shanghai, Shanghai, 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