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

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

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

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Drug: HL151; Drug: Talion Tab

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyeonggi-do
    • Guri-si, Kyeonggi-do, Korea, Republic of, 471-701
      • Hanyang Univ. Guri Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; 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)	Drug: HL151; 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)
ACTIVE_COMPARATOR: Active comparator; 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)	Drug: Talion Tab; 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)	Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 2 (0 week), Visit 3 (1 week)	Visit 2 (0 week), Visit 3 (1 week)
Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks	Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks
Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)	Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 4 (2 weeks)	Visit 4 (2 weeks)

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2017
• Primary Completion (ACTUAL): November 13, 2017
• Study Completion (ACTUAL): January 30, 2018

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Pruritus cutaneus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: HL_HL151_302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No