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a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase â…¢ 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 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) |
|
| Active comparator | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL151 | Drug | 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) |
|
| 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) |
| 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)
| 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 |
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Inclusion Criteria:
Both gender, 19 years ≤ age
Patients with pruritus due to the following diseases
â‘ acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema
â‘¡ contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis
â‘¢ Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo)
â‘£ 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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang Univ. Guri Hospital | Guri-si | Kyeonggi-do | 471-701 | South Korea |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Talion Tab | Drug | 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab) |
|
VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus)
|
| 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)
| 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)
| Visit 4 (2 weeks) |
| D013568 | Pathological Conditions, Signs and Symptoms |