Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis
NCT ID: NCT03222622
Last Updated: 2018-11-14
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.
TERMINATED
PHASE2
136 participants
INTERVENTIONAL
2017-11-29
2018-10-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients
NCT02574091
Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis
NCT07251998
A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis
NCT07265284
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous MK-3222 in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-012)
NCT01936688
A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis
NCT00669916
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
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
65 patients with mild to moderate psoriasis will be randomized to receive 1% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Icotinib hydrochloride cream
Apply topically twice daily for 12 consecutive weeks
Cohort 2
65 patients with mild to moderate psoriasis will be randomized to receive 2% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Icotinib hydrochloride cream
Apply topically twice daily for 12 consecutive weeks
Cohort 3
65 patients with mild to moderate psoriasis will be randomized to receive 4% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Icotinib hydrochloride cream
Apply topically twice daily for 12 consecutive weeks
Cohort 4
65 patients with mild to moderate psoriasis will be randomized to receive placebo cream (blank cream containing no icotinib hydrochloride), applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Placebo cream
Apply topically twice daily for 12 consecutive weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Icotinib hydrochloride cream
Apply topically twice daily for 12 consecutive weeks
Placebo cream
Apply topically twice daily for 12 consecutive weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* In good health condition, with no history of diseases of major organs and no abnormality found on physical examination and vital signs.
* Men and women of childbearing potential must agree to use a contraceptive regimen agreed by the doctor during the trial. Female subjects that are on hormonal contraceptives must continue using the same hormonal contraceptive as that was used in the past 3 months, with the same route of administration and the same dose during the whole study.
* Have signed a written informed consent before entering the study.
Exclusion Criteria
* Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
* Drug-induced psoriasis.
* Present with or had historical interstitial lung disease.
* In the opinion of the investigator, the subjects were not considered appropriate candidates.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tigermed Consulting Co., Ltd
INDUSTRY
Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Min Zheng, PHD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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.
BTP-16322
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.