BridgeMD
Tests treatment safety and results for Seborrheic Dermatitis
Official title ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
ClinicalTrials.gov ID: NCT07404033
What this study is testing
What is ZYG24002 0.5%?
ZYG24002 0.5% is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for seborrheic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Aged 18 (inclusive) to 65 (inclusive) years, of either sex. Male people must have no childbearing potential or agree to adopt contraceptive measures...
- Diagnosed with seborrheic dermatitis by a dermatologist (diagnostic criteria refer to the Expert Consensus on Integrated Traditional Chinese and...
- 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...
- 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...
You likely can't join if
- Severe active seborrheic dermatitis: IGA-SD score of 4 points or extensive skin lesions (BSA \> 10%), accompanied by obvious exudation and infection...
- Comorbidities of other skin diseases that may interfere with study assessments, such as psoriasis, severe acne, rosacea, atopic dermatitis, etc...
- Administration of systemic glucocorticoids, systemic retinoids, immunosuppressants, oral/intravenous antifungals, phototherapy, PDE-4 inhibitors, or...
- Receipt of physical or chemical cosmetic treatments on the head and face within the past month (e.g., intense pulsed light, glycolic acid peels)...
- 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.
See the full eligibility criteria
- Aged 18 (inclusive) to 65 (inclusive) years, of either sex. Male people must have no childbearing potential or agree to adopt contraceptive measures until 3 months after the end of the study; female people of...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- Diagnosis of psychiatric or neurological disorders that may affect compliance or increase study-related risks.
- Pregnancy, lactation, or planned pregnancy; female people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.