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

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.

Criteria

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