Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
NCT ID: NCT03317301
Last Updated: 2018-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
189 participants
INTERVENTIONAL
2017-05-17
2018-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
\- Endpoint: VAS Score Change, Investigator's assessment of overall treatment
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Irritation Potential of ATx201 in Healthy Volunteers
NCT03301870
The Safety and Effectiveness of Local Injection of Antihistamines in Treatment of Inflammatory Skin Diseases
NCT04937101
Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
NCT01170949
A Study of KHK4827 in Subjects With Palmoplantar Pustulosis
NCT04061252
Sensitization Study of ATx201 in Healthy Volunteers
NCT03375957
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
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
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)
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hanyang Univ. Guri Hospital
Guri-si, Kyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HL_HL151_302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.