a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase ? Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0003936
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 196
1) Both gender, 19 years = age
2) Patients with pruritus due to the following diseases
? acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema
? contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis
? Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo)
? 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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline
- Secondary Outcome Measures
Name Time Method Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration;Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline;Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Night) after clinical drug administration compared to baselin;Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline;Investigator's assessment of overall treatment;Safety Evaluation (Adverse Event, Clinical Laboratory Test, Vital Signs, Physical Examination, Electro-Cardiogram)