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RecruitingNCT07404033Updated Jun 17, 2026

ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis

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

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Seborrheic Dermatitis

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Keywords

  • seborrheic dermatitis
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. 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.
  3. 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.
  4. Has not participated in any other clinical trials or used any investigational drugs within the past 3 months.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. 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.
  3. 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.
  4. 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.
  5. A history of known severe hypersensitivity or severe adverse reactions to ZYG24002 or its excipients.
  6. Comorbidities of other skin diseases that may increase the systemic absorption of ZYG24002, such as Netherton syndrome or erythroderma.
  7. Current use of immunosuppressants or diagnosis of immune deficiency.
  8. A history of malignancy within 5 years prior to screening or at screening.
  9. 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.
  10. 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.
  11. 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.
  12. Diagnosis of psychiatric or neurological disorders that may affect compliance or increase study-related risks.
  13. 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.
  14. Diagnosis of alcohol or addictive substance dependence within the past 12 months, or other conditions that the investigator believes may compromise study compliance.
  15. Any other conditions that the investigator deems may interfere with study results or pose an unacceptable safety risk to the participant.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    ZYG24002 0.5%， BID

    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

  • Experimental
    ZYG24002 0.75% ,BID

    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

  • Experimental
    ZYG24002 1%, BID

    Participants apply 1% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days.

    Drug: ZYG24002 1% · Drug: ZYG24002 Placebo

  • Experimental
    ZYG24002 1%, QD

    Participants apply 1% concentration or placebo ZYG24002 Lotion once daily (QD) for a consecutive period of 28 days.

    Drug: ZYG24002 1% · Drug: ZYG24002 Placebo

Interventions

  • DrugZYG24002 0.5%

    0.5% concentration of ZYG24002

  • DrugZYG24002 0.75%

    0.75% concentration of ZYG24002

  • DrugZYG24002 1%

    1% concentration of ZYG24002

  • DrugZYG24002 Placebo

    0% concentration of ZYG24002

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Secondary outcomes

  1. Peak concentration (Cmax)

    Peak concentration (Cmax) after a single dose

    Time frame: Up to 24 hours after first dose

  2. Time to peak concentration (Tmax)

    Time to peak concentration (Tmax) after a single dose

    Time frame: Up to 24 hours after first dose

  3. 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

  4. Steady-state peak concentration (Cmax,ss)

    Steady-state peak concentration (Cmax,ss)

    Time frame: Day 29

  5. Steady-state trough concentration (Cmin,ss)

    Steady-state trough concentration (Cmin,ss)

    Time frame: Day 29

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  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

  16. 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

06

Study locations

1 of 1 sites recruiting
  • Suzhou Municipal Hospital
    Suzhou, Jiangsu 215000, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07404033
Lead sponsor
Sinomune Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Feb 11, 2026
Start date
Apr 24, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 17, 2026

Study contacts

Yaheng Wang
Contact
wangyaheng@sinomune.com
+86-15312798046
Jun Gu, MD
principal investigator · Suzhou Municipal Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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