ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
Condition(s) studied
Investigational drug(s) / intervention(s)
ZYG24002 0.5%: 0.5% concentration of ZYG24002
ZYG24002 0.75%: 0.75% concentration of ZYG24002
ZYG24002 1%: 1% concentration of ZYG24002
ZYG24002 Placebo: 0% concentration of ZYG24002
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.
Eligibility
Primary outcome measure(s)
- The incidence rates of Serious Adverse Events (SAE) during the trial period — 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 — 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 — 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 — 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 — 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) — 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]) — 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) — 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 — 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Suzhou Municipal Hospital | Suzhou | Jiangsu | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07404033 on ClinicalTrials.gov ↗ ← All trials in China