A Phase 3 interventional study of Roflumilast Foam 0.3% and Vehicle foam in Seborrheic Dermatitis, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Not yet recruiting at 52 sites in China. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (part of Huadong Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment
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.
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.
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's planned enrollment of 309 is above the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is the lead sponsor of 50 studies on the registry; 38 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Roflumilast Foam 0.3%
Drug: Vehicle foam
Roflumilast foam 0.3% is applied once daily for 8 weeks.
Vehicle foam is applied once daily for 8 weeks.
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.
Time frame: Baseline, Week 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 8 weeks.
Achievement of an Overall Assessment of Scaling score of 0 at Week 2 and Week 4
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.
Time frame: Baseline, Week 2, Week 4
Achievement of an Overall Assessment of Erythema score of 0 at Week 2 and Week 4
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.
Time frame: Baseline, Week 2, Week 4
Absolute changes from baseline in Scalpdex score at Week 2, Week 4, and Week 8
The Scalpdex score is used to assess the severity of scalp disorders.
Time frame: Baseline, Week 2, Week 4, Week 8
Absolute change from baseline in DLQI/CDLQI score at Week 2, Week 4, Week 8
The DLQI/CDLQI is a simple, self-administered and user-friendly validated questionnaire. The DLQI/CDLQI is designed to measure the health-related quality of life of patients suffering from a skin disease. The DLQI/CDLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI will be completed by participants ages 17 years and older. The CDLQI will be completed by caregivers of participants ages 9-16 years.
Time frame: Baseline, Week 2, Week 4, Week 8
Absolute change from baseline in BSA at Week 2, Week 4, Week 8
The BSA affected by seborrheic dermatitis will be determined by the participant's hand method, where the participant's hand (including fingers) surface area is assumed to equal 1% of body surface area.
Time frame: Baseline, Week 2, Week 4, Week 8
Absolute change from baseline in Overall Assessment of Erythema at Week 2, Week 4, 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).
Time frame: Baseline, Week 2, Week 4, Week 8
Absolute change from baseline in Overall Assessment of Scaling at Week 2, Week 4, 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).
Time frame: Baseline, Week 2, Week 4, Week 8
Absolute change from baseline in Weekly average WI-NRS score at Week 2, Week 4, Week 8
The WI-NRS will be determined by asking the participant's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage change from baseline in Scalpdex score at Week 2, Week 4, and Week 8
The Scalpdex score is used to assess the severity of scalp disorders.
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage change from baseline in DLQI/CDLQI score at Week 2, Week 4, and Week 8
The DLQI/CDLQI is a simple, self-administered and user-friendly validated questionnaire. The DLQI/CDLQI is designed to measure the health-related quality of life of patients suffering from a skin disease. The DLQI/CDLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI will be completed by participants ages 17 years and older. The CDLQI will be completed by caregivers of participants ages 9-16 years.
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage change from baseline in BSA at Week 2, Week 4, and Week 8
The BSA affected by seborrheic dermatitis will be determined by the participant's hand method, where the participant's hand (including fingers) surface area is assumed to equal 1% of body surface area.
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage change from baseline in Overall Assessment of Erythema at Week 2, Week 4, and 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).
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage change from baseline in Overall Assessment of Scaling at Week 2, Week 4, and 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).
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage change from baseline in Weekly average WI-NRS score at Week 2, Week 4, and Week 8
The WI-NRS will be determined by asking the participant's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time frame: Baseline, Week 2, Week 4, Week 8
Percentage of trial participants with daily WI-NRS score of 0 or 1
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").
Time frame: Up to 8 weeks.
Percentage of trial participants with an IGA score of 0 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).
Time frame: Baseline, Week 2, Week 4
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jun 2027, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. →