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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
0.5% concentration of ZYG24002
0.75% concentration of ZYG24002
1% concentration of ZYG24002
0% concentration of ZYG24002
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
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
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
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
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
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
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
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
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
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
Peak concentration (Cmax)
Peak concentration (Cmax) after a single dose
Time frame: Up to 24 hours after first dose
Time to peak concentration (Tmax)
Time to peak concentration (Tmax) after a single dose
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)
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)
Steady-state peak concentration (Cmax,ss)
Time frame: Day 29
Steady-state trough concentration (Cmin,ss)
Steady-state trough concentration (Cmin,ss)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 15
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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
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
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
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
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
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
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
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