Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03317301 |
Recruitment Status :
Completed
First Posted : October 23, 2017
Last Update Posted : August 28, 2018
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pruritus | Drug: HL151 Drug: Talion Tab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 189 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 17, 2017 |
Actual Primary Completion Date : | November 13, 2017 |
Actual Study Completion Date : | January 30, 2018 |
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)
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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)
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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) |
- 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)
- 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)
- 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
- 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)
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Both gender, 19 years ≤ age
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317301
Korea, Republic of | |
Hanyang Univ. Guri Hospital | |
Guri-si, Kyeonggi-do, Korea, Republic of, 471-701 |
Responsible Party: | Hanlim Pharm. Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03317301 |
Other Study ID Numbers: |
HL_HL151_302 |
First Posted: | October 23, 2017 Key Record Dates |
Last Update Posted: | August 28, 2018 |
Last Verified: | October 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pruritus cutaneus |
Pruritus Skin Diseases Skin Manifestations |