Pruritus
Conditions
Keywords
Pruritus cutaneus
Brief summary
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
Interventions
DRUGHL151
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)
DRUGTalion Tab
2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Both gender, 19 years ≤ age 2. 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 3. 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) 4. Those who can ability to record subject diary 5. Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial
Exclusion criteria
1. Patients with pruritus due other medical causes (liver disease, heart failure, etc.) 2. Among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease 3. Patients with systemic infection symptoms at the time of clinical trials 4. Asthmatic patients requiring steroid treatment 5. Patients with Spastic diseases such as epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline | Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) | VAS score: 0 Point \ 10 Point (asymptomatic \ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration | Visit 2 (0 week), Visit 3 (1 week) | VAS score: 0 Point \ 10 Point (asymptomatic \ Maximum pruritus) * Evaluation period: 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 | Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks | VAS score: 0 Point \ 10 Point (asymptomatic \ Maximum pruritus) * Evaluation period: 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 | Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) | VAS score: 0 Point \ 10 Point (asymptomatic \ Maximum pruritus) * Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks) |
| Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method) | Visit 4 (2 weeks) | VAS score: 0 Point \ 10 Point (asymptomatic \ Maximum pruritus) * Evaluation period: Visit 4 (2 weeks) |
Countries
South Korea
Outcome results
None listed