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This study includes a dose escalation part(phase I) and a dose extension part(phase II).
In phase I of this study, a multi-center, randomized, placebo parallel control design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.A total of 40 subjects are expected to be enrolled in about 4 centers.
In phase II of this study, a multi-center, randomized, double-blind parallel, placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.About 120 subjects are expected to be enrolled in about 10 centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1,0.5% Bid | Experimental | Jaktinib hydrochloride cream 0.5% concentration, twice daily |
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| Cohort 1,1.5% Bid | Experimental | Jaktinib hydrochloride cream 1.5% concentration, twice daily |
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| Cohort 1,2.5% Qd | Experimental | Jaktinib hydrochloride cream 2.5% concentration, once daily |
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| Cohort 1,2.5% Bid | Experimental | Jaktinib hydrochloride cream 2.5% concentration, twice daily |
|
| Dose extension: Placebo | Placebo Comparator | Placebo, twice daily |
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| Dose extension: 1.5% Bid | Experimental | Jaktinib hydrochloride cream 1.5% concentration, twice daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib hydrochloride cream | Drug | Jaktinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90) | SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. | at week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Alopecia Tool (SALT) Score | Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| qianjin lu, M.D. | The Second Xiangya Hospital, Central South University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xaingya Hospital,central south university | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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In phase I of this study, Forty enrolled subjects were randomly assigned to four groups at 1:1:1:1. (1) concentration of 0.5%, twice daily (Bid) group; (2) concentration of 1.5%, bid group; (3) concentration of 2.5%, once daily(Qd) group; (4) concentration of 2.5%, bid group.Ten subjects in each group were randomly assigned to receive Jaktinib hydrochloride cream (8 cases) and placebo (2 cases) at 4:1, respectively,The duration of administration was 24 weeks.
In phase II of this trial, 120 Enrolled subjects are randomly assigned to 3 groups (placebo bid group,concentration of 1.5% bid group and concentration of 2.5% bid group).
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| Dose extension: 2.5% Bid | Experimental | Jaktinib hydrochloride cream 2.5% concentration, twice daily |
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| Placebo | Drug | Dose extension: Placebo |
|
| at baseline, at week 12 and at week 24 |
| D017437 |
| Skin and Connective Tissue Diseases |