Seborrheic DermatitisPhase 3NCT07683806
Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis
A Phase 3 study testing Roflumilast Foam 0.3% in people with Seborrheic Dermatitis, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 52 sites in China.
Trial summary
This study will assess the safety and efficacy of Roflumilast foam 0.3% (ZORYVE®) versus vehicle applied once a day for 8 weeks by trial participants with seborrheic dermatitis. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Roflumilast Foam 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 52 sitesChina
- Study dates
- 24 Aug 2026to 3 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ages 9 years and older (inclusive) at the time of consent.
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at screening as determined by the Investigator. Stable disease for the past 4 weeks.
- Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
- An Investigator Global Assessment (IGA) disease severity of at least moderate ('3') at baseline.
- Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
- Trial participants in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
Show all 9Show fewer
- Women of Childbearing Potential (WOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline (Visit 2). WOCBP must have used highly effective contraception for at least 4 weeks prior to the first study drug administration, and agree to continue using highly effective contraception for 2 months after the last dose. If hormonal contraceptives are used, the dosage must have been stable for a minimum of 4 weeks before the first administration. Alternatively, WOCBP shall use barrier contraception from the time of signing the ICF through 2 months after the last dose. All WOCBP shall have no plan to conceive or donate oocytes throughout the study period.
- Trial participants are considered reliable and capable of adhering to the protocol and visit schedule according to the Investigator judgment.
- Participants legally competent to sign and give informed consent or (for children/adolescents) assent with consent of a parent(s) or legal guardian.
Who cannot join
- Trial participants with any serious medical condition or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- Any conditions in the treatment area judged by the investigator at screening or baseline that may interfere with efficacy assessment (e.g., confirmed cutaneous bacterial, viral or parasitic infections, psoriasis, atopic dermatitis, acne, as well as pigmentation, extensive scars, pigmentary lesions, sunburn, etc.).
- Trial participants with active pityriasis/tinea amiantacea.
- Current or history of cancer within 5 years from Screening with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix.
- A clinically relevant history of abuse of alcohol or other drugs within 6 months prior to screening.
- Known or suspected severe renal insufficiency as evidenced by calculated creatinine clearance <30 mL/min, or moderate to severe hepatic disorders (Child-Pugh B or C).
Show all 27Show fewer
- History of severe depression, suicidal ideation or behavior, Baseline/Screening C-SSRS (for adolescents and adults 12 years old and older) indicative of suicidal behavior, whether lifetime or recent/recurrent.
- Trial participants with PHQ-8 (≥18 years old, inclusive) score ≥10 at Screening or Baseline visits, or children aged 9 to 11 years (inclusive), following discussion with their legal representatives, the investigator assesses the presence of depressive symptoms or suicide/depression risk.
- Systemic administration of antifungals, glucocorticoids, immunosuppressants, retinoids, roflumilast tablets, apremilast tablets, or systemic traditional Chinese medicine known or suspected to affect seborrheic dermatitis within 4 weeks prior to the first study drug administration.
- Receipt of phototherapy, sunbeds or any other light-emitting devices within 4 weeks prior to the first study drug administration, or planned excessive exposure of the treatment area to natural or artificial light.
- Use of topical medications or treatments within 2 weeks prior to the first study drug administration, including but not limited to topical antifungals, topical glucocorticoids, topical calcineurin inhibitors, topical phosphodiesterase 4 (PDE-4) inhibitors, sulfur-containing preparations, azelaic acid, metronidazole, medical devices, or topical traditional Chinese medicine known or suspected to affect seborrheic dermatitis.
- Use of medicinal shampoos or medical devices containing antifungals, glucocorticoids, zinc pyrithione, selenium sulfide, coal tar, or keratolytic agents (e.g., salicylic acid) within 2 weeks prior to the first study drug administration.
- Receipt of topical treatments on the scalp for indications other than seborrheic dermatitis within 2 weeks prior to the first study drug administration, if such treatments may alter scalp skin conditions (e.g., topical minoxidil for androgenetic alopecia, retinoids or tar preparations for scalp psoriasis, topical anti-allergic agents for allergic dermatitis, and certain oil-control or anti-dandruff shampoos).
- Use of potent cytochrome P450 (CYP) 3A4 inhibitors systemically within 2 weeks prior to the first study drug administration.
- Intravenous administration of antibiotics or antiviral agents within 1 week prior to the first study drug administration.
- Use of etanercept within 4 weeks prior to the first study drug administration, or use of any other biologics within 12 weeks or 5 half-lives (whichever is longer) prior to the first study drug administration.
- Participation in any clinical trial of biologics within 12 weeks or 5 half-lives (whichever is longer), any clinical trial of oral formulations within 5 half-lives, or any clinical trial of topical formulations within 2 weeks prior to the first study drug administration (excluding participants who only signed the ICF and did not receive any study drug or device).
- Participants who have undergone major surgery within 4 weeks prior to the first study drug administration or are scheduled to receive major surgery during the study period .
- Prior use of roflumilast cream or roflumilast foam.
- Known allergies or hypersensitivity to component(s) of the investigational product which includes roflumilast, petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate.
- Liver function test results excursions that exceed: AST or ALT > 2x ULN; Total bilirubin: 1.5x ULN or >ULN and ≤1.5x ULN and direct bilirubin is >35% of total bilirubin; ALP ≥ 2x ULN.
- History of human immunodeficiency virus (HIV) infection or suspected HIV infection, or positive HIV antibody at screening; positive hepatitis B surface antigen (HBsAg), or negative HBsAg with positive hepatitis B core antibody and HBV-DNA level above the upper limit of normal reference range; positive hepatitis C virus (HCV) antibody with HCV-RNA level above the upper limit of normal reference range; positive treponemal-specific antibody for syphilis (Participants with negative non-specific syphilis antibody and clinically diagnosed as inactive infection may be enrolled). Participants with indeterminate screening results are not recommended for enrollment.
- Trial participants/caregivers unable to apply product to the scalp due to physical limitations if the trial participants has current or history of seborrheic dermatitis involving the scalp.
- Females who are pregnant, or are breast-feeding.
- Trial participants who are family members of the clinical study site, or clinical study staff, or sponsor, or family members residing in the same household of enrolled trial participants.
- Trial participants, parent(s)/legal guardian(s) of children/adolescent trial participants who are unable to communicate, read, or understand the study.
- Any condition that in the Investigator's assessment would preclude the trial participants from participating in the study
Trial locations and contacts
52 sites in 1 country. Contact the study team or a site near you to ask about taking part.
52 sites in 1 country
China52 sites
Beijing Children's Hospital, Capital Medical University Baoding Hospital
Baoding, Hebei
Chunping Shen, 0312-3377882, bdetgcpgy@163.com
Beijing Aerospace General Hospital
Beijing
Wenbin Liu, 010-68380114, GCP_711@163.com
Beijing Children's Hospital, Capital Medical University Baoding Hospital
Beijing
Zigang Xu, 010-59616161, bjchildrens_qa@126.com
Beijing Huairou Hospital
Beijing
Haihong Zhang, 010-60686699, bjhrgcp@163.com
China-Japan Friendship Hospital
Beijing
Yong Cui, 010-84205645, zryygcp@163.com
Peking University People's Hospital
Beijing
Jianzhong Zhang, 18001315877, rmzjz@126.com
Cheng Zhou, 18910291182, rmpkzc@126.com
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Congjun Jiang, 15155281266, fessor5195@163.com
Second Hospital of Jilin University
Changchun, Jilin
Fuqiu Li, 13944156576, zhangxuan@jlu.com
The First People's Hospital of Changde
Changde, Hunan
Jianjian Zhu, 15873658886, lidocute@163.com
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Lina Tan, 0731-88618931, tanlinawork@163.com
Xiangya Hospital of Central South University
Changsha, Hunan
Juan Su, 0731-84327938, 3694944834@qq.com
Chengdu Second People's Hospital
Chengdu, Sichuan
Bin Yin, 028-67830010, binyin666@163.com
Chengdu Women's Children's Central Hospital
Chengdu, Sichuan
Yao Lu, 028-63806390, Ptapeapea@163.com
huan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan
Huiying Wan, 028-87393999, 83478331@qq.com
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Hengguang Zhao, 023-62888289, zhgvip1@sina.com
The first affilated hospital of Fujian Medical university
Fuzhou, Fujian
Niu Xiang, 0591-87981264, fjydfyjg@163.com
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Xiaohua Wang, 020-83482482, smudh-ctc@vip.163.com
Hainan Fifth People's Hospital
Haikou, Hainan
Huiming Zeng, 0898-66512550, swyjgb2024@163.com
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Liming Wu, 0571-56007501, 18957118053@163.com
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
Xiuzu Song, 0571-87823189, hz3ygcp@163.com
Xingang Wu
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Yi Tang, 13968076453, tangyi.hz@163.com
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Bingxue Bai, 15114517408, bxuebdd@163.com
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan
Feng Wang, 15073402992, denver180@126.com
The First Hospital of Jiaxing
Jiaxing, Zhejiang
Shenghua Li, 0573-89976377, 296174019@qq.com
Jinan Municipal Central Hospital
Jinan, Shandong
Lihua Wang, 15318816237, 15318816237@163.com
Shandong First Medical University Affiliated Hospital of Dermatology
Jinan, Shandong
Furen Zhang, 0531-87298847, zhangfurenlcsy@163.com
Jingzhou Central Hospital
Jingzhou, Hubei
Yi Sun, 0716-8497225, hbjzyyywlc@163.com
Jingzhou First People's Hospital
Jingzhou, Hubei
Jin Gong, 18163138676, 790917@qq.com
The Second Affiliated Hospital of Henan University of science and technology
Luoyang, Henan
Bin Zhang, 18537925196, 15537990507@163.com
Sir Run Run Hospital,Nanjing Medical University
Nanjing, Jiangsu
Bin Chen, 025-87115857, chenbin@njmu.edu.cn
Nanyang Central Hospital
Nanyang, Henan
Kunpeng Bian, 0377-65037050, nyszxyygcpjg@163.com
Ningbo No.2 Hospital
Ningbo, Zhejiang
Jinyan Wang, 0574-83870375, nbwangjinyan@126.com
Sanmenxia Central Hospital
Sanmenxia, Henan
Danhong Jiao, 0398-3118657, zxyyjgb888@162.com
Children's Hospital of Shanghai
Shanghai
Qiufang Qian, 021-62474880, qianqf@shchildren.com.cn
Huashan Hospital, Fudan University
Shanghai
Jinran Lin, 13816798151, linjinran@huashan.org.cn
Shanghai Dermatology Hospital
Shanghai
Yuling Shi, 021-36803000, shiyuling1973@126.com
Shanghai General Hospital
Shanghai
Zhouwei Wu, 021-63240090, 18957118053@163.com
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning
Xiaodong Li, 18002478468, lilicmu@163.com
Liaoning Provincial People's Hospital
Shenyang, Liaoning
Lili Zhu, 17702486330, zhulili011006@126.com
Shenzhen Children's Hospital
Shenzhen, Guangdong
Ping Li, 0755-83008184, szetywsy@wjw.sz.gov.cn
Shiyan People's Hospital
Shiyan, Hubei
Zudong Meng, 0719-8637462, 792925910@qq.com
Taiyuan Central Hospital
Taiyuan, Shanxi
Xuping Niu, 13834507233, zxyy5852@126.com
The First Affiliated Hospital of Wannan Medical Hospital
Wuhu, Anhui
Caifeng He, 0553-5739209, yjsjgbgs@163.com
The Second Affiliated Hospital of Wannan Medical University
Wuhu, Anhui
Fei Wang, 0553-2871009, 1494812279@qq.com
Wuxi No. 2 People's Hospital
Wuxi, Jiangsu
Rushan Xia, 18861843704, wxeyxrs@163.com
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian
Mingkai Ji, 0592-6152222, Mingkai_ji@163.com
Yancheng No.1 People's Hospital
Yancheng, Jiangsu
Pingping Qin, 13601413122, 13601413122@139.com
Yichang Central People's Hospital
Yichang, Hubei
Xianfeng Fang, 0717-6487063, ycsgcp@163.com
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang
Lunfei Liu, 0579-89935052, liulunfei_zeyy@163.com
Shanxi Yuncheng Central Hospital
Yuncheng, Shanxi
Juanli Fan, 0359-6397832, 409172906@163.com
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
Hui Xu, 13815474886, xuhuiraian@sina.com
Zhengzhou Central Hospital
Zhenzhou, Henan
Zixue Chen, 18236915956, czxpf@sina.com
About this study
Official title: A Phase 3 Multicenter, Randomized, Parallel Group, Double Blind, Vehicle-controlled Study of the Efficacy and Safety of Roflumilast Foam 0.3% (ZORYVE®) in Trial Participants With Seborrheic Dermatitis
This study will assess the safety and efficacy of Roflumilast foam 0.3% (ZORYVE®) versus vehicle applied once a day for 8 weeks by trial participants with seborrheic dermatitis.
Read the detailed description
This is a phase 3, randomized, parallel group, double blind, vehicle-controlled study in which Roflumilast foam 0.3% (ZORYVE®) or vehicle foam is applied QD for 8 weeks to trial participants 9 years of age and older with seborrheic dermatitis affecting the scalp and/or rest of body.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Roflumilast Foam 0.3%, Vehicle foam
- Keywords
- Roflumilast foam, seborrheic dermatitis
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast Foam 0.3%Drug
Roflumilast foam 0.3% is applied once daily for 8 weeks.
Vehicle foamDrug
Vehicle foam is applied once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast foam 0.3% | Experimental | Not described Receives: Drug: Roflumilast Foam 0.3% |
| Vehicle foam | Placebo comparator | Not described Receives: Drug: Vehicle foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of trial participants with IGA success at Week 8
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). IGA success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement.
Measured: Baseline, Week 8
Secondary outcomes (8)
Percentage of trial participants with WI-NRS success in subjects with a Baseline WI-NRS pruritus score of ≥4
The WI-NRS is a simple, single item to assess the patient-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"). WI-NRS success is defined as the achievement of a ≥4-point improvement from baseline in WI-NRS pruritus score.
Measured: Baseline, Week 2, Week 4, Week 8
Percentage of trial participants with IGA success at Week 2 and Week 4
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). IGA success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement.
Measured: Baseline, Week 2, Week 4
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at Week 8
Overall Assessment of Scaling are static qualitative evaluations, involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability.
Measured: Baseline, Week 8
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at Week 8
Overall Assessment of Erythema is a static qualitative evaluation, involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability.
Measured: Baseline, Week 8
Achievement of an IGA score of 0 at Week 8
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). IGA score of 0 is described as no erythema, no scaling (hypo-hyperpigmentation can be present).
Measured: Baseline, Week 8
Safety: TEAE
Treatment-emergent adverse events (TEAEs), including details regarding incidence, severity, time of onset, duration, causality to the investigational product, clinical outcome, and actions taken with the study treatment.
Measured: Throughout the study, up to 9 weeks
Safety: Other Safety Endpoint
Numbers of participants with any of the followings: local intolerability, abnormal vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure), weight loss of >5% from baseline, hypopigmentation and/or hyperpigmentation, abnromal laboratory tests (including hematology, chemistry, and urinalysis), abnormal Patient Health Questionnaire Depression Scale (PHQ-8)/modified Adolescent Patient Health Questionnaire Depression Scale (PHQ-A), and/or Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: Up to 8 weeks.
Pharmacokinetic (PK) endpoint
To analyze the trough plasma concentrations of Roflumilast and its N-oxide at Week 4 and Week 8 after administration.
Measured: Up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start24 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion3 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 309 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683806
- Sponsor's protocol ID
- HDM3014-3-301
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Parallel Group, Double Blind, Vehicle-controlled Study of the Efficacy and Safety of Roflumilast Foam 0.3% (ZORYVE®) in Trial Participants With Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT07683806
- Acronym / sponsor ID
- HDM3014-3-301
- Conditions
- Seborrheic Dermatitis
- Keywords
- Roflumilast foam, seborrheic dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 3 Aug 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of Roflumilast foam 0.3% (ZORYVE®) versus vehicle applied once a day for 8 weeks by trial participants with seborrheic dermatitis.
Detailed description
This is a phase 3, randomized, parallel group, double blind, vehicle-controlled study in which Roflumilast foam 0.3% (ZORYVE®) or vehicle foam is applied QD for 8 weeks to trial participants 9 years of age and older with seborrheic dermatitis affecting the scalp and/or rest of body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast foam 0.3% | Experimental | Drug: Roflumilast Foam 0.3% |
| Vehicle foam | Placebo comparator | Drug: Vehicle foam |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females ages 9 years and older (inclusive) at the time of consent.
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at screening as determined by the Investigator. Stable disease for the past 4 weeks.
- Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
- An Investigator Global Assessment (IGA) disease severity of at least moderate ('3') at baseline.
- Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
Key exclusion criteria (27 listed)
- Trial participants with any serious medical condition or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- Any conditions in the treatment area judged by the investigator at screening or baseline that may interfere with efficacy assessment (e.g., confirmed cutaneous bacterial, viral or parasitic infections, psoriasis, atopic dermatitis, acne, as well as pigmentation, extensive scars, pigmentary lesions, sunburn, etc.).
- Trial participants with active pityriasis/tinea amiantacea.
- Current or history of cancer within 5 years from Screening with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix.
- A clinically relevant history of abuse of alcohol or other drugs within 6 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast Foam 0.3%Roflumilast foam 0.3% is applied once daily for 8 weeks. | Drug | Roflumilast foam 0.3% |
| Vehicle foamVehicle foam is applied once daily for 8 weeks. | Drug | Vehicle foam |
Primary outcome
Percentage of trial participants with IGA success at Week 8
Time frame: Baseline, Week 8
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). IGA success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement.
8 secondary outcomes
Percentage of trial participants with WI-NRS success in subjects with a Baseline WI-NRS pruritus score of ≥4
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage of trial participants with IGA success at Week 2 and Week 4
Time frame: Baseline, Week 2, Week 4
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at Week 8
Time frame: Baseline, Week 8
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at Week 8
Time frame: Baseline, Week 8
Achievement of an IGA score of 0 at Week 8
Time frame: Baseline, Week 8
Safety: TEAE
Time frame: Throughout the study, up to 9 weeks
Safety: Other Safety Endpoint
Time frame: Up to 8 weeks.
Pharmacokinetic (PK) endpoint
Time frame: Up to 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Seborrheic Dermatitis
Not yet recruiting
TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
Cradle Cap, Seborrheic Dermatitis
RecruitingEarly Phase 1
The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.
Seborrheic Dermatitis
RecruitingPhase 1
ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
Seborrheic Dermatitis
Recruiting
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
Hair Transplantation, Seborrheic Dermatitis
Not yet recruiting
Sebum Metabolomics and Lipidomics for Clinical Applications
Acne, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast Foam 0.3% in people with Seborrheic Dermatitis, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 52 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 9 inclusion and 27 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huadong Medicine (+86-0571-89918267, cxyguweizhi@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of trial participants with IGA success at Week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.