Status:
COMPLETED
Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Pruritus
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 Chan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT03317301
Start Date
May 17 2017
End Date
January 30 2018
Last Update
August 28 2018
Active Locations (1)
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1
Hanyang Univ. Guri Hospital
Guri-si, Kyeonggi-do, South Korea, 471-701