Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZYG24002 0.5%, BID | Experimental | Participants apply 0.5% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. |
|
| ZYG24002 0.75% ,BID | Experimental | Participants apply 0.75% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. |
|
| ZYG24002 1%, BID | Experimental | Participants apply 1% concentration or placebo ZYG24002 Lotion twice daily (BID) for a consecutive period of 28 days. |
|
| ZYG24002 1%, QD | Experimental | Participants apply 1% concentration or placebo ZYG24002 Lotion once daily (QD) for a consecutive period of 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZYG24002 0.5% | Drug | 0.5% concentration of ZYG24002 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Peak concentration (Cmax) after a single dose | Up to 24 hours after first dose |
| Time to peak concentration (Tmax) | Time to peak concentration (Tmax) after a single dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaheng Wang | Contact | +86-15312798046 | wangyaheng@sinomune.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Gu, MD | Suzhou Municipal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Municipal Hospital | Recruiting | Suzhou | Jiangsu | 215000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ZYG24002 0.75% |
| Drug |
0.75% concentration of ZYG24002 |
|
| ZYG24002 1% | Drug | 1% concentration of ZYG24002 |
|
| ZYG24002 Placebo | Drug | 0% concentration of ZYG24002 |
|
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. |
| 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) | 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 | 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 | 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 | Through study completion, an average of 1 year |
| 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) | Up to 24 hours after first dose |
| Steady-state peak concentration (Cmax,ss) | Steady-state peak concentration (Cmax,ss) | Day 29 |
| Steady-state trough concentration (Cmin,ss) | Steady-state trough concentration (Cmin,ss) | 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 | 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 | 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. | Day 15 |
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Day 29 |
| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D017443 | Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
Not provided
Not provided