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

Hanlim Pharm

Status and phase: Completed; Phase 3

Conditions: Pruritus

Treatments: Drug: Talion Tab; Drug: HL151

Study type: Interventional

Funder types: Industry

Identifiers

NCT03317301

HL_HL151_302

Details and patient eligibility

About

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

Enrollment: 189 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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189 participants in 2 patient groups

Experimental

Experimental group

Description:

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)

Treatment:

Drug: HL151

Active comparator

Active Comparator group

Description:

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)

Treatment:

Drug: Talion Tab