---
title: Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
nct_id: NCT03317301
overall_status: COMPLETED
phase: PHASE3
sponsor: Hanlim Pharm. Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Pruritus
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03317301.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03317301"
ct_last_update_post_date: 2018-08-28
last_seen_at: "2026-05-12T06:29:24.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

**Official Title:** 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

**NCT ID:** [NCT03317301](https://clinicaltrials.gov/study/NCT03317301)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 189
- **Lead Sponsor:** Hanlim Pharm. Co., Ltd.
- **Conditions:** Pruritus
- **Start Date:** 2017-05-17
- **Completion Date:** 2018-01-30
- **CT.gov Last Update:** 2018-08-28

## 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 Change, Investigator's assessment of overall treatment

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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)
- **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)

## Interventions

- **HL151** (DRUG) — 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)
- **Talion Tab** (DRUG) — 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)

## Primary Outcomes

- **Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline** _(time frame: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks))_ — VAS score: 0 Point \~ 10 Point (asymptomatic \~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

## Secondary Outcomes

- **Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration** _(time frame: 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** _(time frame: 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** _(time frame: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks))_
- **Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)** _(time frame: Visit 4 (2 weeks))_

## Locations (1)

- Hanyang Univ. Guri Hospital, Guri-si, Kyeonggi-do, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hanyang univ. guri hospital|guri-si|kyeonggi-do|south korea` — added _(2026-05-12)_

---

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