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Atopic Dermatitis (AD)Phase 3NCT06631170

Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

A Phase 3 study testing Roflumilast Cream 0.15% in people with Atopic Dermatitis (AD), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 61 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Atopic Dermatitis (AD)
What is being tested?
Roflumilast Cream 0.15%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
354 participants
Where
61 sitesChina
Study dates
21 Nov 2024to 13 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

China61 sites

  • The First affiliated Hospital of Baotou College

    Baotou, Neimenggu

  • Beijing Aerospace General Hospital

    Beijing, Beijing Municipality

  • Beijing Children's Hospital

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital, CMU

    Beijing, Beijing Municipality

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • The First People's Hospital of Changde City

    Changde, Hunan

  • Hunan Children's Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital

    Changsha, Hunan

  • Chengdu Second People's Hospital

    Chengdu, Sichuan

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan

  • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • Chongqing Medical University Affiliated Second Hospital

    Chongqing, Chongqing Municipality

  • People's Hospital Affiliated to Chongqing Three Gorges Medical College

    Chongqing, Chongqing Municipality

  • Dalian Dermatology Hospital

    Dalian, Liaoning, China

  • Dalian Municipal Women and Children's Medical Center

    Dalian, Liaoning

  • Dongguan People's Hospital

    Dongguan, Guangdong

  • The Sixth People's Hospital of Dongguan

    Dongguan, Guangdong

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The Second affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Hainan General Hospital

    Haikou, Hainan

  • The Fifth People's Hospital of Hainan Province

    Haikou, Hainan

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang

  • Jinan Central Hospital

    Jinan, Shandong

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Jingzhou Central Hospital

    Jingzhou, Hubei

  • Kunming Children's Hospital

    Kunming, Hainan, China

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • Liuzhou People's Hospital

    Liuzhou, Guangxi

  • The Second Hospital affiliated to Henan University of Science and Technology

    Luoyang, Henan

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi

  • The Second affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Sir Run Run Hospital Nanjing Medical University

    Nanjing, Jiangsu

  • Nanyang Central Hospital

    Nanyang, Henan

  • The Second Hospital of Ningbo

    Ningbo, Zhejiang

  • Panjin Liaohe Oilfield Gem Flower Hospital

    Panjin, Liaoning

  • Hiser Medical Center of Qingdao

    Qingdao, Shandong

  • Sanmenxia Central Hospital

    Sanmenxia, Henan

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong

  • Union Shenzhen Hospital

    Shenzhen, Guangdong

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei

  • TCM Hospital of Shi Jia Zhuang City

    Shijiazhuang, Hebei

  • Taizhou Central Hospital

    Taizhou, Zhejiang

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • The Second affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

  • J.Y Hospital of TCM

    Wuxi, Jiangsu

  • People's hospital of Wuxi

    Wuxi, Jiangsu

  • Wuxi Second People's Hospital

    Wuxi, Jiangsu

  • The Second affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • The Second affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian

  • Xingtai People's Hospital

    Xingtai, Hebei

  • Yichang Central People's Hospital

    Yichang, Hubei

  • Henan Children's Hospital Zhengzhou Children's Hospital

    Zhengzhou, Henan

  • Zhengzhou Central Hospital

    Zhengzhou, Henan

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
Roflumilast Cream 0.15%, Vehicle cream
Keywords
Roflumilast cream, Atopic dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roflumilast Cream 0.15%Drug

    Roflumilast cream 0.15% is applied once daily for 4 weeks

  • Vehicle creamDrug

    Vehicle cream is applied once daily for 4 weeks

Study groups in NCT06631170
Study groupRoleWhat they receive
Roflumilast cream 0.15%ExperimentalActive comparator
Receives: Drug: Roflumilast Cream 0.15%
Vehicle creamPlacebo comparatorPlacebo comparator
Receives: Drug: Vehicle cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, week 4

Secondary outcomes (6)

  1. In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, 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).

    Measured: Baseline, week 4

  2. Percentage of subjects with vIGA-AD of "clear" or "almost clear"

    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).

    Measured: Baseline, week 4

  3. In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS

    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").

    Measured: Baseline, week 4

  4. Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)

    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.

    Measured: Baseline, week 4

  5. Safety: treatment emergence adverse events

    Incidence, severity, and causal relationship of treatment emergence adverse events (TEAE), TEAEs leading to withdrawal and death.

    Measured: Up to 4 weeks

  6. Trough concentration (Ctrough)

    Trough concentration of plasma roflumilast and its N-oxide

    Measured: Week 2, week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start21 Nov 2024
  3. Primary completion27 May 2025
  4. Study completion13 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631170
Sponsor's protocol ID
HDM3014-2-301
Status last verified
Aug 2025
First submitted
30 Sep 2024
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roflumilast Cream 0.15% in people with Atopic Dermatitis (AD), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 61 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with vIGA-AD success (time frame: Baseline, week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06631170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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