Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

Study Overview
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Brief Summary
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a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus. - Endpoint: VAS Score Change, Investigator's assessment of overall treatment

Official Title
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a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

Conditions
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Pruritus

Intervention / Treatment
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* Drug: HL151
* Drug: Talion Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both gender, 19 years ≤ age Patients with pruritus due to the following diseases ① acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema ② contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis ③ Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo) ④ systemic skin pruritus, focal skin pruritus In visit 2, during the run-in period previous week the VAS score of day and night time were 2 or more average points per day (maximum 4 points) Those who can ability to record subject diary Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial Exclusion Criteria: Patients with pruritus due other medical causes (liver disease, heart failure, etc.) Among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease Patients with systemic infection symptoms at the time of clinical trials Asthmatic patients requiring steroid treatment Patients with Spastic diseases such as epilepsy

Ages Eligible for Study
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Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Experimental: 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (1Tab)+Talion Tab (Placebo)(1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (Placebo)(1Tab) | Drug: HL151<br>* 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (1Tab)+Talion Tab (Placebo)(1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (Placebo)(1Tab)<br>|
| Active Comparator: Active comparator<br>Comparator: 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab) | Drug: Talion Tab<br>* 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline | VAS score: 0 Point   10 Point (asymptomatic   Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) | Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration | VAS score: 0 Point   10 Point (asymptomatic   Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week) | Visit 2 (0 week), Visit 3 (1 week) | 
| Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline | VAS score: 0 Point   10 Point (asymptomatic   Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks | Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks | 
| Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline | VAS score: 0 Point   10 Point (asymptomatic   Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) | Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) | 
| Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method) | VAS score: 0 Point   10 Point (asymptomatic   Maximum pruritus) Evaluation period: Visit 4 (2 weeks) | Visit 4 (2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pruritus cutaneus