Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

• Status: Terminated
• Trial end date: 2018-10-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Collaborator: Tigermed Consulting Co., Ltd

Criteria

Inclusion Criteria:

• Clinical diagnosed plaque psoriasis for at least six months with multiple treatable areas (i.e. the lesion should not only on the face, scalp, genitals or skinfolds) which covers less than 10% of the total Body Surface Area (BSA), and affected area on the limb and/or trunk ≥ 1% BSA. The long diameter and thickness of target plaque psoriasis was ≥ 2cm and ≥2, respectively.

• 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:

• Psoriasis guttata, psoriasis punctata, erythrodermic psoriasis, pustular psoriasis, psoriasis arthritis.

• 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.