Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus

Study Overview
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Brief Summary
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The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.

Official Title
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A Phase II, Single Center, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of PAC-14028 Cream in Dermal Pruritus

Conditions
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Skin Pruritus

Intervention / Treatment
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* Drug: PAC-14028
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients at the age of 20 to 65 years old (both inclusive) Pruritus test ≥ 5cm (10cm Visual Analogue Scale [VAS]) at baseline Eczema or dry skin on the study drug application site Women of childbearing potential should have a negative urine pregnancy test at screening and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period. Voluntarily signed written informed consent forms for study participation. Exclusion Criteria: Pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease. Chronic skin diseases such as malignant tumor or chronic urticaria, among skin diseases. Simple pruritus caused by allergic substances such as scabies or insect bites. Presence of symptoms of generalized infection at the time of study participation. Previous local treatment or antibiotics administration for pruritus within 7 days prior to study participation. Previous use of oral steroids within 1 month and local steroids within 2 weeks prior to study participation. History of physical treatment for pruritus, including phototherapy, within 1 month prior to study participation. Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period. Renal function impairment with creatinine level Hepatic function impairment with aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) Pregnant and lactating women Participation in another clinical study within 1 month prior to screening. Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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 0.3%<br>PAC-14028 cream 0.3%, twice daily for 28 days | Drug: PAC-14028<br>* Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks<br>* Other names: PAC-14028 Cream 1.0%;|
| Experimental: PAC-14028 cream 1.0%<br>PAC-14028 cream 1.0%, twice daily for 28days | Drug: PAC-14028<br>* Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks<br>* Other names: PAC-14028 Cream 1.0%;|
| Placebo Comparator: Vehicle<br>Vehicle, twice daily for 28days | Other: Vehicle<br>* Participants received topical Vehicle twice daily for 4 weeks<br>* Other names: Vehicle of PAC-14028 Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) | Patient reported outcome of pruritis measurement on a change in visual analog scale | Baseline through Study Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success rate |  | Baseline through Study Day 28 | 
| Change in specified symptom sum score (SRRC) Index |  | Baseline through Study Day 28 | 
| Change in transepidermal water loss |  | Baseline through Study Day 28 | 
| Change in skin hydration |  | Baseline through Study Day 28 |