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This is a multicenter, randomized, open-label, parallel-group, Phase II clinical trial designed to evaluate the efficacy and safety of HW211026 in adult patients with actinic keratosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HW211026 dose 1 | Experimental |
| |
| HW211026 dose 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HW211026 | Drug | HW211026 ointment dose 1,applied topically on face once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance Rate | Percentage of participants achieving 100% clearance of actinic keratosis lesions. | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lesion counts | Change from baseline in the counts of actinic keratosis lesions. | Days 14, 28, 42 and 56 |
| The number and severity of treatment emergent adverse events (TEAEs) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Skin Disease Hospital | Shanghai | 200443 | China |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| HW211026 |
| Drug |
HW211026 ointment dose 2,applied topically on face once daily. |
|
TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing.
| Baseline up to Day 57 |
| D017437 |
| Skin and Connective Tissue Diseases |