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Completed

NCT Number: NCT03317301

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

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang Univ. Guri Hospital

Guri-si, Kyeonggi-do, 471-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both gender, 19 years ≤ age
  • 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

  • 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)
  • Those who can ability to record subject diary
  • Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial

Exclusion criteria

  • Patients with pruritus due other medical causes (liver disease, heart failure, etc.)
  • Among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease
  • Patients with systemic infection symptoms at the time of clinical trials
  • Asthmatic patients requiring steroid treatment
  • Patients with Spastic diseases such as epilepsy

Treatment and study plan

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

  1. 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

  1. Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration

    Time frame: Visit 2 (0 week), Visit 3 (1 week)

    VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus)

    • Evaluation period: Visit 2 (0 week), Visit 3 (1 week)

  2. 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

    VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus)

    • Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks

  3. 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)

    VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus)

    • Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

  4. Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)

    Time frame: Visit 4 (2 weeks)

    VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus)

    • Evaluation period: Visit 4 (2 weeks)

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 23, 2017
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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