A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus

Study Overview
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Brief Summary
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The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.

Official Title
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Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients

Conditions
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Skin Pruritus

Intervention / Treatment
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* Drug: PAC-14028 cream 0.1%
* Drug: PAC-14028 cream 0.3%
* Drug: PAC-14028 cream 1.0%
* Drug: PAC-14028 cream vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 19 - 70 years Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg) Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more Exclusion Criteria: Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound Patients with the symptom of systemic infection at the time of the participation in the clinical study Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks Patients with a history of taking oral steroid agent within 4 weeks Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks Pregnant or breast-feeding women Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAC-14028 cream 0.1%<br>PAC-14028 cream 0.1%, Twice daily for 4 weeks | Drug: PAC-14028 cream 0.1%<br>* Topical application<br>|
| Experimental: PAC-14028 cream 0.3%<br>PAC-14028 cream 0.3%, Twice daily for 4 weeks | Drug: PAC-14028 cream 0.3%<br>* Topical application<br>|
| Experimental: PAC-14028 cream 1.0%<br>PAC-14028 cream 1.0%, Twice daily for 4 weeks | Drug: PAC-14028 cream 1.0%<br>* Topical application<br>|
| Placebo Comparator: PAC-14028 cream vehicle<br>PAC-14028 cream vehicle, Twice daily for 4 weeks | Drug: PAC-14028 cream vehicle<br>* Topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intensity of pruritus as measured by 10 cm VAS |  | Week 4 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success rate (A decrease in VAS by 2 or more is judged as a success) |  | Week 4 from baseline | 
| Change in Overall Dry Skin (ODS) score |  | Week 4 from baseline | 
| Change in Transepidermal Water Loss (TEWL) |  | Week 4 from baseline |