A Phase 1 interventional study of ZYG24002 0.5% and ZYG24002 0.75% in Seborrheic Dermatitis, sponsored by Sinomune Pharmaceutical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Sinomune Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ib clinical trial conducted in adult patients with mild to moderate seborrheic dermatitis (IGA-SD score of 2-3 points). The study aims to evaluate the safety, tolerability, and steady-state pharmacokinetic (PK) profiles of three concentrations (0.5%, 0.75%, and 1.0%) of ZYG24002 Lotion following continuous topical application once daily (QD) or twice daily (BID) for 28 days, and to conduct a preliminary exploration of the drug's efficacy.
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's planned enrollment of 48 is below the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →Sinomune Pharmaceutical Co., Ltd is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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.
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.
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.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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 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.
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.
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.
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.
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.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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 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.
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.
Participants apply 0.5% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days.
Drug: ZYG24002 0.5% · Drug: ZYG24002 Placebo
Participants apply 0.75% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days.
Drug: ZYG24002 0.75% · Drug: ZYG24002 Placebo
Participants apply 1% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days.
Drug: ZYG24002 1% · Drug: ZYG24002 Placebo
Participants apply 1% concentration or placebo ZYG24002 Lotion once daily (QD) for a consecutive period of 28 days.
Drug: ZYG24002 1% · Drug: ZYG24002 Placebo
0.5% concentration of ZYG24002
0.75% concentration of ZYG24002
1% concentration of ZYG24002
0% concentration of ZYG24002
The incidence rates of Serious Adverse Events (SAE) during the trial period
Safety assessment will include the types and incidence rates of all serious adverse events (SAE) occurring during the study period; and the causal relationship between SAE and the study drug (assessed using a five-level evaluation method: Definite, Probable, Possible, Unlikely, Unrelated).
Time frame: Through study completion, an average of 1 year
The incidence rate of adverse events (AE) occurring during the treatment period with severity grade ≥ 3
Calculate the incidence rate of adverse events (AE) occurring during the treatment period with severity grade ≥ 3 (per CTCAE V5.0 criteria) ; record the specific types, severity, and causal relationship with the study drug of the aforementioned treatment-emergent adverse events (TEAE).
Time frame: Through study completion, an average of 1 year
The incidence rate of adverse events (AE) occurring during the treatment period resulting in treatment discontinuation
Calculate the incidence rate of adverse events (AE) occurring during the treatment period with resulting in treatment discontinuation; record the specific types, severity, and causal relationship with the study drug of the aforementioned treatment-emergent adverse events (TEAE).
Time frame: Through study completion, an average of 1 year
Local Tolerability (LT) Indicator: the proportion of study participants with local cutaneous reactions of severity grade ≥ 2 during the study period
Calculate the proportion of study participants with local cutaneous reactions (including stinging sensation, burning sensation, pruritus, erythema, and edema/papules) of severity grade ≥ 2 during the study period
Time frame: Through study completion, an average of 1 year
Local Tolerability (LT) Indicator: the proportion of study participants with treatment interruption or discontinuation due to local tolerability adverse reactions
Record the proportion of study participants with treatment interruption or discontinuation due to local tolerability adverse reactions, as well as the occurrence frequency, types, and trends of change of the aforementioned local tolerability reactions.
Time frame: Through study completion, an average of 1 year
Supportive Safety Endpoints - The incidence rate of Adverse Events (AE) (including Grade 1-2)
Record the types, incidence rates, severity, and drug-relatedness of all adverse events (AE) (including Grade 1-2) occurring during the treatment period (Day 1 - Day 35 ± 2)
Time frame: Through study completion, an average of 1 year
Supportive Safety Endpoints - the incidence rate of abnormalities in vital signs (blood pressure [BP], heart rate [HR], body temperature [BT])
Calculate the incidence rate of abnormalities in vital signs (blood pressure \[BP\], heart rate \[HR\], body temperature \[BT\]); Record the changes in vital signs (blood pressure \[BP\], heart rate \[HR\], body temperature \[BT\]) and their clinical significance among study participants in each dose group during the treatment and follow-up periods
Time frame: Through study completion, an average of 1 year
Supportive Safety Endpoints - The incidence rate of abnormalities in laboratory test indicators (including blood routine, blood biochemistry, urine routine)
Calculate the incidence rate and severity of abnormalities in laboratory test indicators (including blood routine, blood biochemistry, urine routine) among study participants in each dose group during the treatment and follow-up periods
Time frame: Through study completion, an average of 1 year
Supportive Safety Endpoints - The incidence rate of abnormalities in electrocardiogram (ECG) examinations
Calculate the incidence rate of abnormalities in electrocardiogram (ECG) examinations and their clinical significance among study participants in each dose group during the treatment and follow-up periods
Time frame: Through study completion, an average of 1 year
Peak concentration (Cmax)
Peak concentration (Cmax) after a single dose
Time frame: Up to 24 hours after first dose
Time to peak concentration (Tmax)
Time to peak concentration (Tmax) after a single dose
Time frame: Up to 24 hours after first dose
Single-dose exposure (Area Under the Curve from 0 to τ, AUC0-τ, τ=24 h for QD, τ=12 h for BID)
Single-dose exposure (Area Under the Curve from 0 to τ, AUC0-τ, τ=24 h for QD, τ=12 h for BID)
Time frame: Up to 24 hours after first dose
Steady-state peak concentration (Cmax,ss)
Steady-state peak concentration (Cmax,ss)
Time frame: Day 29
Steady-state trough concentration (Cmin,ss)
Steady-state trough concentration (Cmin,ss)
Time frame: Day 29
Accumulation ratio (Rac): The ratio of steady-state Cmax,ss to single-dose Cmax
Accumulation ratio (Rac): The ratio of steady-state Cmax,ss to single-dose Cmax
Time frame: Day 29
Accumulation ratio (Rac): the ratio of steady-state AUC to single-dose AUC
Accumulation ratio (Rac): the ratio of steady-state AUC to single-dose AUC
Time frame: Day 29
IGA-SD Treatment Success Rate after treatment on Day 15±1
Defined as the proportion of study participants whose Investigator's Global Assessment for Seborrheic Dermatitis (IGA-SD, 0-4 point scale) score of the target area reaches 0 (Clearance) or 1 (Near Clearance) after treatment on Day 15±1 , with an improvement of ≥ 2 grades from baseline.
Time frame: Day 15
IGA-SD Treatment Success Rate after treatment on Day 29
Defined as the proportion of study participants whose Investigator's Global Assessment for Seborrheic Dermatitis (IGA-SD, 0-4 point scale) score of the target area reaches 0 (Clearance) or 1 (Near Clearance) after treatment on Day 29, with an improvement of ≥ 2 grades from baseline.
Time frame: Day 29
Change in Total Erythema Score on Day 15±1
The change in total erythema score (0-3 point scale) on Day 15±1 compared with baseline
Time frame: Day 15
Change in Total Erythema Score on Day 29
The change in total erythema score (0-3 point scale) on Day 29 compared with baseline
Time frame: Day 29
Change in Total Scaling Score on Day 15±1
The change in total scaling score (0-3 point scale) on Day 15±1 compared with baseline
Time frame: Day 15
Change in Total Scaling Score on Day 29
The change in total scaling score (0-3 point scale) on Day 29 compared with baseline
Time frame: Day 29
Change in Worst Itch Intensity (WI-NRS) on Day 15±1
The change in Worst Itch Intensity (WI-NRS, 0-10 point scale) on Day 15±1 compared with baseline
Time frame: Day 15
Change in Worst Itch Intensity (WI-NRS) on Day 29
The change in Worst Itch Intensity (WI-NRS, 0-10 point scale) on Day 29 compared with baseline
Time frame: Day 29
Change in DLQI Score
The change in Dermatology Life Quality Index (DLQI) (0-30 point scale) score on Day 29 compared with baseline
Time frame: Day 29
Plan to share: No
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Sinomune Pharmaceutical Co., Ltd