a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase ? Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.

Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase ? Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0003936

Enrollment

196

Registered

2019-05-16

Start date

2017-05-17

Completion date

Unknown

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. Run-in Period(Single Blind) Screening point: HL151 (Placebo)(1Tab)+Talion Tab (Placebo)(1Tab), 2 times a day(Day, Night), 1 week of treatment 2. Treatment Period(Double Blind) Experimental:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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
Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Korea, Republic of

Contacts

Public ContactSeona Sin

Hanyang University Guri Hospital

seona135790@gmail.com+82-2-560-2280

Outcome results