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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.
Icotinib Hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for the treatment of advanced nonsmall- cell lung cancer (NSCLC) in China in its oral form. As EGFR is implicated in the pathogenesis of psoriasis, icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a single-center, randomized, doubleblind, placebo-controlled study of 0.5%, 1.0%, 2.0%, 4.0% icotinib hydrochloride cream by topical administration. Icotinib hydrochloride cream will be applied to subjects with mild to moderate psoriasis. Approximately 40 subjects will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1-Experimental | Experimental | 8 patients with mild to moderate psoriasis will be randomized to receive 0.5% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site. |
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| Cohort 1-Placebo | Placebo Comparator | 2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site. |
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| Cohort 2-Experimental | Experimental | 8 patients with mild to moderate psoriasis will be randomized to receive 1.0% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site. |
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| Cohort 2-Placebo | Placebo Comparator | 2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site. |
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| Cohort 3-Experimental | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% Icotinib hydrochloride cream | Drug | Topical administration for twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety in patients with mild to moderate psoriasis | Incidence and severity of Adverse Events (AE), Physical Examinations, Vital signs (temperature, Heart Rate (HR), BP and respiration); Clinical laboratory assessments (serum chemistry, hematology, C-reactive protein , fecal and urinalysis); ECG; | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance-related skin reactions in patients with mild to moderate psoriasis at the treatment site | Skin irritation and allergy observation (including redness, swelling,rash, itching, pain) recorded by grades | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion severity | Erythema , scale , thickness of target site on patients with mild to moderate psoriasis | 28 days |
| Lesion area | 28 days | |
Inclusion Criteria:
Exclusion Criteria:
Topical anti-psoriasis treatment in 2 weeks, e.g. corticosteroids, retinoids acid, anthranol, tars, keratolytics. Vitamin D analogues or local immune regulator treatment in 4 weeks; Emollient or cosmetics in 24 hours; Any psoriasis vaccine, or have participated in any psoriasis vaccine trial; Biologics treatment in 12 weeks, e.g. Alefacept, Etanercept, Infliximab, Adalimumab, Ustekinumab, Efalizumab; Any phototherapy or systemic treatment in 4 weeks, e.g. corticosteroids, methotrexate, retinoids acids, ciclosporin; Long time exposure to natural light or artificial UV, or will have such exposure; Use of drug known to harm certain organ in 12 weeks; Participated in any clinical trial in 4 weeks, or have plan to participate any trial during treatment period;
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| Name | Affiliation | Role |
|---|---|---|
| Min Zheng | The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) | Principal Investigator |
| Zourong Ruan | The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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8 patients with mild to moderate psoriasis will be randomized to receive 2.0% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
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| Cohort 3-Placebo | Placebo Comparator | 2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site. |
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| Cohort 4-Experimental | Experimental | 8 patients with mild to moderate psoriasis will be randomized to receive 4.0% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site. |
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| Cohort 4-Placebo | Placebo Comparator | 2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site. |
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| 1.0% Icotinib hydrochloride cream | Drug | Topical administration for twice daily |
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| 2.0% Icotinib hydrochloride cream | Drug | Topical administration for twice daily |
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| 4.0% Icotinib hydrochloride cream | Drug | Topical administration for twice daily |
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| Placebo | Drug | Topical administration for twice daily |
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| Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis |
| 28 days |
| Physician's Global Assessment(PGA) in patients with mild to moderate psoriasis | 28 days |
| Dermatology Life Quality Index (DLQI) in patients with mild to moderate psoriasis | 28 days |
| Time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis | 12 hours |
| Peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis | 12 hours |
| Area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream from zero(0) hours to time (t) in patients with mild to moderate psoriasis | 12 hours |
| Area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream from zero (0) hours to infinity (∞) in patients with mild to moderate psoriasis | 12 hours |
| Half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis | 12 hours |
| Time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis | 24 hours |
| Stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis | 24 hours |
| Area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream from zero(0) hours to time (t) in patients with mild to moderate psoriasis | 24 hours |
| Area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream from zero (0) hours to infinity (∞) in patients with mild to moderate psoriasis | 24 hours |
| Half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis | 24 hours |