New foam could tame stubborn scalp and face rash

NCT ID NCT07683806

Disease control Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jul 06, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This trial tests whether a once-daily foam containing roflumilast can treat seborrheic dermatitis, a common skin condition causing red, flaky patches on the scalp, face, and trunk. About 300 people ages 9 and older with moderate to severe disease will apply either the active foam or a placebo foam for 8 weeks. The main goal is to see if the rash clears or nearly clears, with a secondary focus on reducing itch.

What this could mean

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

Active substance: roflumilast foam 0.3%
What this could lead to: If successful, this foam could offer a new, once-daily treatment option for seborrheic dermatitis, potentially clearing or nearly clearing the rash and reducing itch.
What could go wrong: This is a phase 3 trial, but results may not confirm benefit over placebo. Side effects from the foam are possible, and it may not work for everyone.

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

About 309 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

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

9 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. Males and females ages 9 years and older (inclusive) at the time of consent. 2. 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. 3. Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas. 4. An Investigator Global Assessment (IGA) disease severity of at least moderate ('3') at baseline. 5. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline. 6. 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. 7. 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. 8. Trial participants are considered reliable and capable of adhering to the protocol and visit schedule according to the Investigator judgment. 9. Participants legally competent to sign and give informed consent or (for children/adolescents) assent with consent of a parent(s) or legal guardian. Exclusion Criteria: 1. 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. 2. 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.). 3. Trial participants with active pityriasis/tinea amiantacea. 4. 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. 5. A clinically relevant history of abuse of alcohol or other drugs within 6 months prior to screening. 6. 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). 7. 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. 8. 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. 9. 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. 10. 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. 11. 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. 12. 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. 13. 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). 14. Use of potent cytochrome P450 (CYP) 3A4 inhibitors systemically within 2 weeks prior to the first study drug administration. 15. Intravenous administration of antibiotics or antiviral agents within 1 week prior to the first study drug administration. 16. 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. 17. 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). 18. 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 . 19. Prior use of roflumilast cream or roflumilast foam. 20. 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. 21. 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. 22. 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. 23. 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. 24. Females who are pregnant, or are breast-feeding. 25. 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. 26. Trial participants, parent(s)/legal guardian(s) of children/adolescent trial participants who are unable to communicate, read, or understand the study. 27. Any condition that in the Investigator's assessment would preclude the trial participants from participating in the study

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Conditions

The condition(s) this trial relates to.

seborrheic dermatitis

As listed by the trial registrant

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

Seborrheic dermatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

52 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China
Beijing Aerospace General Hospital

Beijing, China
Beijing Children's Hospital, Capital Medical University Baoding Hospital

Baoding, Hebei, China
Beijing Children's Hospital, Capital Medical University Baoding Hospital

Beijing, China
Beijing Huairou Hospital

Beijing, China
Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China
Chengdu Second People's Hospital

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

Chengdu, Sichuan, China
Children's Hospital of Shanghai

Shanghai, China
China-Japan Friendship Hospital

Beijing, China
Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China
Hainan Fifth People's Hospital

Haikou, Hainan, China
Hangzhou First People's Hospital

Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China
Huashan Hospital, Fudan University

Shanghai, China
Jinan Municipal Central Hospital

Jinan, Shandong, China
Jingzhou Central Hospital

Jingzhou, Hubei, China
Jingzhou First People's Hospital

Jingzhou, Hubei, China
Liaoning Provincial People's Hospital

Shenyang, Liaoning, China
Nanyang Central Hospital

Nanyang, Henan, China
Ningbo No.2 Hospital

Ningbo, Zhejiang, China
Peking University People's Hospital

Beijing, China
Sanmenxia Central Hospital

Sanmenxia, Henan, China
Second Hospital of Jilin University

Changchun, Jilin, China
Shandong First Medical University Affiliated Hospital of Dermatology

Jinan, Shandong, China
Shanghai Dermatology Hospital

Shanghai, China
Shanghai General Hospital

Shanghai, China
Shanxi Yuncheng Central Hospital

Yuncheng, Shanxi, China
Shenzhen Children's Hospital

Shenzhen, Guangdong, China
Shiyan People's Hospital

Shiyan, Hubei, China
Sir Run Run Hospital,Nanjing Medical University

Nanjing, Jiangsu, China
Taiyuan Central Hospital

Taiyuan, Shanxi, China
The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China
The First Affiliated Hospital of Wannan Medical Hospital

Wuhu, Anhui, China
The First Hospital of Jiaxing

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

Changde, Hunan, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Yiwu, Zhejiang, China
The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China
The Second Affiliated Hospital of Henan University of science and technology

Luoyang, Henan, China
The Second Affiliated Hospital of Wannan Medical University

Wuhu, Anhui, China
The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, China
The first affilated hospital of Fujian Medical university

Fuzhou, Fujian, China
Wuxi No. 2 People's Hospital

Wuxi, Jiangsu, China
Xiangya Hospital of Central South University

Changsha, Hunan, China
Yancheng No.1 People's Hospital

Yancheng, Jiangsu, China
Yichang Central People's Hospital

Yichang, Hubei, China
Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China
Zhengzhou Central Hospital

Zhenzhou, Henan, China
huan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

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