New lotion shows promise for flaky scalp and skin
NCT ID NCT07404033
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new lotion (ZYG24002) in 48 adults with mild to moderate seborrheic dermatitis, a common skin condition causing redness and flaking. Participants will apply the lotion daily for 28 days to see if it is safe and tolerable. The goal is to find the best dose for future studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Suzhou Municipal Hospital
RECRUITINGSuzhou, Jiangsu, 215000, China
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