New eczema cream shows promise in phase 3 trial

NCT ID NCT06631170

Symptom relief Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tested a once-daily cream called roflumilast (0.15%) in 354 people aged 6 and older with mild to moderate atopic dermatitis (eczema). Participants applied the cream or a placebo for 4 weeks. The main goal was to see if the cream could make skin clear or almost clear. This study is already completed, and results will show if roflumilast is a safe and effective new option for eczema.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Roflumilast cream 0.15%
What this could lead to: If successful, this cream could offer a new, once-daily option to ease symptoms and clear skin in people with mild to moderate atopic dermatitis.
What could go wrong: This is a short, 4-week study, and results may not last long-term. The cream may not work for everyone, and side effects like skin irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

354 people

The number who actually took part.

Started

Nov 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects aged ≥ 6 years at screening. 2. 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. 3. Have stable disease for the past 4 weeks prior to screening. 4. Have mild or moderate AD at baseline. 5. Have BSA affected by AD of 3%-20% at baseline. 6. 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. 7. Being in good health as judged by the Investigator. 8. Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities. Exclusion Criteria: 1. 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. 2. Previous treatment with roflumilast cream. 3. 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. 4. Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose. 5. Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose. 6. Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study. 7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening. 8. 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. 9. 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.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis (AD)

Contacts and locations

Locations

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 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
Chengdu Second People's Hospital

Chengdu, Sichuan, China
Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China
Chongqing Medical University Affiliated Second Hospital

Chongqing, Chongqing Municipality, China
Dalian Dermatology Hospital

Dalian, Liaoning, China, China
Dalian Municipal Women and Children's Medical Center

Dalian, Liaoning, China
Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China
Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China
Dongguan People's Hospital

Dongguan, Guangdong, China
Fujian Medical University Union Hospital

Fuzhou, Fujian, China
Hainan General Hospital

Haikou, Hainan, China
Hangzhou First People's Hospital

Hangzhou, Zhejiang, China
Henan Children's Hospital Zhengzhou Children's Hospital

Zhengzhou, Henan, China
Hiser Medical Center of Qingdao

Qingdao, Shandong, China
Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China
Hunan Children's Hospital

Changsha, Hunan, China
J.Y Hospital of TCM

Wuxi, Jiangsu, China
Jinan Central Hospital

Jinan, Shandong, China
Jingzhou Central Hospital

Jingzhou, Hubei, China
Kunming Children's Hospital

Kunming, Hainan, China, China
Liaocheng People's Hospital

Liaocheng, Shandong, China
Liuzhou People's Hospital

Liuzhou, Guangxi, China
Nanyang Central Hospital

Nanyang, Henan, China
Panjin Liaohe Oilfield Gem Flower Hospital

Panjin, Liaoning, China
People's Hospital Affiliated to Chongqing Three Gorges Medical College

Chongqing, Chongqing Municipality, China
People's hospital of Wuxi

Wuxi, Jiangsu, China
Qilu Hospital of Shandong University

Jinan, Shandong, China
Renmin Hospital of Wuhan University

Wuhan, Hubei, China
Sanmenxia Central Hospital

Sanmenxia, Henan, China
Shanghai Children's Hospital

Shanghai, Shanghai Municipality, China
Shenzhen Children's Hospital

Shenzhen, Guangdong, China
Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

Chengdu, Sichuan, China
Sir Run Run Hospital Nanjing Medical University

Nanjing, Jiangsu, China
TCM Hospital of Shi Jia Zhuang City

Shijiazhuang, Hebei, China
Taizhou Central Hospital

Taizhou, Zhejiang, China
The Fifth People's Hospital of Hainan Province

Haikou, Hainan, China
The First Bethune Hospital of Jilin University

Changchun, Jilin, China
The First Hospital of Jiaxing

Jiaxing, Zhejiang, China
The First People's Hospital of Changde City

Changde, Hunan, China
The First affiliated Hospital of Baotou College

Baotou, Neimenggu, China
The Second Hospital affiliated to Henan University of Science and Technology

Luoyang, Henan, China
The Second Hospital of Jiaxing

Jiaxing, Zhejiang, China
The Second Hospital of Ningbo

Ningbo, Zhejiang, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, China
The Second affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China
The Second affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The Second affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China
The Second affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China
The Second affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, China
The Sixth People's Hospital of Dongguan

Dongguan, Guangdong, China
Union Shenzhen Hospital

Shenzhen, Guangdong, China
Wuxi Second People's Hospital

Wuxi, Jiangsu, China
Xiangya Hospital

Changsha, Hunan, China
Xingtai People's Hospital

Xingtai, Hebei, China
Yichang Central People's Hospital

Yichang, Hubei, China
Zhengzhou Central Hospital

Zhengzhou, Henan, China

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