Seborrheic DermatitisPhase 1NCT07404033
ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
A Phase 1 study testing ZYG24002 0.5%, ZYG24002 0.75% and ZYG24002 1% in people with Seborrheic Dermatitis, run by Sinomune Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- ZYG24002 0.5%, ZYG24002 0.75% and ZYG24002 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2026to 31 Dec 2026
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 (inclusive) to 65 (inclusive) years, of either sex. Male subjects must have no childbearing potential or agree to adopt contraceptive measures until 3 months after the end of the study; female subjects of childbearing potential must be non-pregnant and non-lactating, and adopt reliable contraceptive measures during the study period and within 3 months after the last dose.
- Diagnosed with seborrheic dermatitis by a dermatologist (diagnostic criteria refer to the Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Seborrheic Dermatitis (2024 Edition) and the 2015 Asian Consensus on Seborrheic Dermatitis), with a disease duration of ≥ 3 months; baseline Investigator's Global Assessment for Seborrheic Dermatitis (IGA-SD) score (0-4 point scale) of 2 (mild) or 3 (moderate); at baseline, the overall scores for erythema and scaling are at least mild severity (score 1) respectively. The involved body surface area (BSA%) is ≤ 10%, and skin lesions are distributed in at least two anatomical sites such as the scalp, face, and trunk.
- No obvious signs of infection at the test site (e.g., pustules, crusts caused by bacterial infection). The subject is in good general skin condition at enrollment, with no other active skin lesions that may interfere with the clinical assessment.
- Has not participated in any other clinical trials or used any investigational drugs within the past 3 months.
- Study participants provide informed consent to participate in this study, sign the informed consent form (ICF), are able to understand the study requirements, and are willing to complete all scheduled visits and examinations in accordance with the investigator's instructions.
Who cannot join
- Severe active seborrheic dermatitis: IGA-SD score of 4 points or extensive skin lesions (BSA > 10%), accompanied by obvious exudation and infection, requiring systemic therapy. Participants whose disease activity is deemed unsuitable for study enrollment by the investigator (including but not limited to situations where 4 weeks of placebo-only treatment may lead to unacceptable disease progression).
- Comorbidities of other skin diseases that may interfere with study assessments, such as psoriasis, severe acne, rosacea, atopic dermatitis, etc., which would confound the observation of seborrheic dermatitis lesions.
- Administration of systemic glucocorticoids, systemic retinoids, immunosuppressants, oral/intravenous antifungals, phototherapy, PDE-4 inhibitors, or JAK inhibitors within 4 weeks; topical glucocorticoids, calcineurin inhibitors, PDE-4 inhibitors, antifungals, retinoids, keratolytics, selenium/tar-containing preparations on the study area within 2 weeks; any biologic agents within 6 months; or potent CYP3A4 inhibitors/inducers within 4 weeks.
- Receipt of physical or chemical cosmetic treatments on the head and face within the past month (e.g., intense pulsed light, glycolic acid peels), resulting in temporary skin barrier dysfunction that has not yet recovered to normal.
- A history of known severe hypersensitivity or severe adverse reactions to ZYG24002 or its excipients.
- Comorbidities of other skin diseases that may increase the systemic absorption of ZYG24002, such as Netherton syndrome or erythroderma.
Show all 15Show fewer
- Current use of immunosuppressants or diagnosis of immune deficiency.
- A history of malignancy within 5 years prior to screening or at screening.
- Poorly controlled chronic diseases, including but not limited to endocrine disorders (e.g., diabetes mellitus with significantly elevated fasting blood glucose and obvious clinical symptoms, hyperthyroidism); a history of severe cardiovascular and cerebrovascular diseases (e.g., myocardial infarction, stroke); active peptic ulcers or chronic inflammatory bowel disease, etc.
- Abnormal liver function: ALT or AST > 2 × upper limit of normal (ULN), or total bilirubin > 1.5 × ULN at screening; abnormal renal function: serum creatinine > 1.5 × ULN; or other clinically significant abnormal laboratory findings that are deemed unsuitable for enrollment by the investigator.
- Human immunodeficiency virus (HIV) infection; active hepatitis C virus (HCV) infection (anti-HCV positive); active hepatitis B virus (HBV) infection (HBV-DNA > 2000 IU/mL or 10⁴ CPs/mL); or positive treponema pallidum antibody with evidence of active infection.
- Diagnosis of psychiatric or neurological disorders that may affect compliance or increase study-related risks.
- Pregnancy, lactation, or planned pregnancy; female subjects of childbearing potential who have not initiated reliable contraceptive measures at least 30 days prior to the first dose and who cannot commit to maintaining such measures for 3 months after the last dose.
- Diagnosis of alcohol or addictive substance dependence within the past 12 months, or other conditions that the investigator believes may compromise study compliance.
- Any other conditions that the investigator deems may interfere with study results or pose an unacceptable safety risk to the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
Jun Gu, Doctor, +86-18930939371, gujun79@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅰb Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Different Concentrations of ZYG24002 Lotion in Adult Patients With Mild to Moderate Seborrheic Dermatitis
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.
- Conditions
- Seborrheic Dermatitis
- Being tested
- ZYG24002 0.5%, ZYG24002 0.75%, ZYG24002 1%, ZYG24002 Placebo
- Keywords
- 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.
ZYG24002 0.5%Drug
0.5% concentration of ZYG24002
ZYG24002 0.75%Drug
0.75% concentration of ZYG24002
ZYG24002 1%Drug
1% concentration of ZYG24002
ZYG24002 PlaceboDrug
0% concentration of ZYG24002
| Study group | Role | What they receive |
|---|---|---|
| ZYG24002 0.5%， BID | Experimental | Participants apply 0.5% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. Receives: Drug: ZYG24002 0.5%; Drug: ZYG24002 Placebo |
| ZYG24002 0.75% ,BID | Experimental | Participants apply 0.75% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. Receives: Drug: ZYG24002 0.75%; Drug: ZYG24002 Placebo |
| ZYG24002 1%, BID | Experimental | Participants apply 1% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. Receives: Drug: ZYG24002 1%; Drug: ZYG24002 Placebo |
| ZYG24002 1%, QD | Experimental | Participants apply 1% concentration or placebo ZYG24002 Lotion once daily (QD) for a consecutive period of 28 days. Receives: Drug: ZYG24002 1%; Drug: ZYG24002 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (16)
Peak concentration (Cmax)
Peak concentration (Cmax) after a single dose
Measured: Up to 24 hours after first dose
Time to peak concentration (Tmax)
Time to peak concentration (Tmax) after a single dose
Measured: 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)
Measured: Up to 24 hours after first dose
Steady-state peak concentration (Cmax,ss)
Steady-state peak concentration (Cmax,ss)
Measured: Day 29
Steady-state trough concentration (Cmin,ss)
Steady-state trough concentration (Cmin,ss)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start24 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinomune Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Gu, MD, Principal investigator, Suzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404033
- Sponsor's protocol ID
- ZYG-24002-Ⅰ-01-2025-02
- Status last verified
- Jun 2026
- First submitted
- 25 Jan 2026
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅰb Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Different Concentrations of ZYG24002 Lotion in Adult Patients With Mild to Moderate Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT07404033
- Acronym / sponsor ID
- ZYG-24002-Ⅰ-01-2025-02
- Conditions
- Seborrheic Dermatitis
- Keywords
- seborrheic dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sinomune Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Feb 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZYG24002 0.5%， BID | Experimental | Drug: ZYG24002 0.5%, Drug: ZYG24002 PlaceboParticipants apply 0.5% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. |
| ZYG24002 0.75% ,BID | Experimental | Drug: ZYG24002 0.75%, Drug: ZYG24002 PlaceboParticipants apply 0.75% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. |
| ZYG24002 1%, BID | Experimental | Drug: ZYG24002 1%, Drug: ZYG24002 PlaceboParticipants apply 1% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. |
| ZYG24002 1%, QD | Experimental | Drug: ZYG24002 1%, Drug: ZYG24002 PlaceboParticipants apply 1% concentration or placebo ZYG24002 Lotion once daily (QD) for a consecutive period of 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 (inclusive) to 65 (inclusive) years, of either sex. Male subjects must have no childbearing potential or agree to adopt contraceptive measures until 3 months after the end of the study; female subjects of childbearing potential must be non-pregnant and non-lactating, and adopt reliable contraceptive measures during the study period and within 3 months after the last dose.
- Diagnosed with seborrheic dermatitis by a dermatologist (diagnostic criteria refer to the Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Seborrheic Dermatitis (2024 Edition) and the 2015 Asian Consensus on Seborrheic Dermatitis), with a disease duration of ≥ 3 months; baseline Investigator's Global Assessment for Seborrheic Dermatitis (IGA-SD) score (0-4 point scale) of 2 (mild) or 3 (moderate); at baseline, the overall scores for erythema and scaling are at least mild severity (score 1) respectively. The involved body surface area (BSA%) is ≤ 10%, and skin lesions are distributed in at least two anatomical sites such as the scalp, face, and trunk.
- No obvious signs of infection at the test site (e.g., pustules, crusts caused by bacterial infection). The subject is in good general skin condition at enrollment, with no other active skin lesions that may interfere with the clinical assessment.
- Has not participated in any other clinical trials or used any investigational drugs within the past 3 months.
- Study participants provide informed consent to participate in this study, sign the informed consent form (ICF), are able to understand the study requirements, and are willing to complete all scheduled visits and examinations in accordance with the investigator's instructions.
Key exclusion criteria (15 listed)
- Severe active seborrheic dermatitis: IGA-SD score of 4 points or extensive skin lesions (BSA > 10%), accompanied by obvious exudation and infection, requiring systemic therapy. Participants whose disease activity is deemed unsuitable for study enrollment by the investigator (including but not limited to situations where 4 weeks of placebo-only treatment may lead to unacceptable disease progression).
- Comorbidities of other skin diseases that may interfere with study assessments, such as psoriasis, severe acne, rosacea, atopic dermatitis, etc., which would confound the observation of seborrheic dermatitis lesions.
- Administration of systemic glucocorticoids, systemic retinoids, immunosuppressants, oral/intravenous antifungals, phototherapy, PDE-4 inhibitors, or JAK inhibitors within 4 weeks; topical glucocorticoids, calcineurin inhibitors, PDE-4 inhibitors, antifungals, retinoids, keratolytics, selenium/tar-containing preparations on the study area within 2 weeks; any biologic agents within 6 months; or potent CYP3A4 inhibitors/inducers within 4 weeks.
- Receipt of physical or chemical cosmetic treatments on the head and face within the past month (e.g., intense pulsed light, glycolic acid peels), resulting in temporary skin barrier dysfunction that has not yet recovered to normal.
- A history of known severe hypersensitivity or severe adverse reactions to ZYG24002 or its excipients.
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 |
|---|---|---|
| ZYG24002 0.5%0.5% concentration of ZYG24002 | Drug | ZYG24002 0.5%， BID |
| ZYG24002 0.75%0.75% concentration of ZYG24002 | Drug | ZYG24002 0.75% ,BID |
| ZYG24002 1%1% concentration of ZYG24002 | Drug | ZYG24002 1%, BID, ZYG24002 1%, QD |
| ZYG24002 Placebo0% concentration of ZYG24002 | Drug | ZYG24002 0.5%， BID, ZYG24002 0.75% ,BID, ZYG24002 1%, BID, ZYG24002 1%, QD |
Primary outcome
The incidence rates of Serious Adverse Events (SAE) during the trial period
Time frame: Through study completion, an average of 1 year
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).
The incidence rate of adverse events (AE) occurring during the treatment period with severity grade ≥ 3
Time frame: Through study completion, an average of 1 year
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).
The incidence rate of adverse events (AE) occurring during the treatment period resulting in treatment discontinuation
Time frame: Through study completion, an average of 1 year
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).
Local Tolerability (LT) Indicator: the proportion of study participants with local cutaneous reactions of severity grade ≥ 2 during the study period
Time frame: Through study completion, an average of 1 year
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
Local Tolerability (LT) Indicator: the proportion of study participants with treatment interruption or discontinuation due to local tolerability adverse reactions
Time frame: Through study completion, an average of 1 year
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.
Supportive Safety Endpoints - The incidence rate of Adverse Events (AE) (including Grade 1-2)
Time frame: Through study completion, an average of 1 year
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)
Supportive Safety Endpoints - the incidence rate of abnormalities in vital signs (blood pressure [BP], heart rate [HR], body temperature [BT])
Time frame: Through study completion, an average of 1 year
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
Supportive Safety Endpoints - The incidence rate of abnormalities in laboratory test indicators (including blood routine, blood biochemistry, urine routine)
Time frame: Through study completion, an average of 1 year
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
Supportive Safety Endpoints - The incidence rate of abnormalities in electrocardiogram (ECG) examinations
Time frame: Through study completion, an average of 1 year
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
16 secondary outcomes
Peak concentration (Cmax)
Time frame: Up to 24 hours after first dose
Time to peak concentration (Tmax)
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)
Time frame: Up to 24 hours after first dose
Steady-state peak concentration (Cmax,ss)
Time frame: Day 29
Steady-state trough concentration (Cmin,ss)
Time frame: Day 29
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
Time frame: Day 29
IGA-SD Treatment Success Rate after treatment on Day 15±1
Time frame: Day 15
IGA-SD Treatment Success Rate after treatment on Day 29
Time frame: Day 29
Change in Total Erythema Score on Day 15±1
Time frame: Day 15
Change in Total Erythema Score on Day 29
Time frame: Day 29
Change in Total Scaling Score on Day 15±1
Time frame: Day 15
Change in Total Scaling Score on Day 29
Time frame: Day 29
Change in Worst Itch Intensity (WI-NRS) on Day 15±1
Time frame: Day 15
Change in Worst Itch Intensity (WI-NRS) on Day 29
Time frame: Day 29
Change in DLQI Score
Time frame: Day 29
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 17 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Jun Gu, MD principal investigator
Suzhou Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZYG24002 0.5%, ZYG24002 0.75% and ZYG24002 1% in people with Seborrheic Dermatitis, run by Sinomune Pharmaceutical Co., Ltd at 1 site 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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yaheng Wang (+86-15312798046, wangyaheng@sinomune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rates of Serious Adverse Events (SAE) during the trial period (time frame: Through study completion, an average of 1 year). The study lists 9 primary outcomes in all. 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 17 Jun 2026.