Phase
Condition
Vitiligo
Treatment
SHR0302 Placebo Tablets
SHR0302 Base Placebo Gel
SHR0302 Base Gel
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign the informed consent form before the clinical trial.
On the day of signing the informed consent form, the age must be between 18 and 75years old (inclusive), and it can be either male or female.
The subjects and their partners had no intention of having children during the studyperiod and within one month after the administration of the drug, did not donatesperm or eggs, and voluntarily adopted effective contraceptive measures. The serumpregnancy test results of the female subjects must be negative and they must not bein the lactation period.
During the screening process, it was clinically diagnosed as non-segmental vitiligo.
Throughout the entire research process, the participants agreed to stop using alltreatments related to vitiligo as well as any cosmetic products with therapeuticeffects.
Exclusion
Exclusion Criteria:
Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjectspreviously diagnosed with other skin pigmentation disorders.
When the facial skin lesions caused by vitiligo cover more than 33% of the area withwhite hair.
During the screening period or at the baseline, there were other active skin lesionsor skin infections that might interfere with the use of the study drug or theevaluation of the drug's efficacy.
Subjects with a history of related infections/communicable diseases orinfection/contagion history.
Known or suspected history of immunosuppression.
Tuberculosis (TB) or latent tuberculosis infection.
Positive for human immunodeficiency virus antibody HIV-Ab, positive forsyphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, orhepatitis B virus (HBV) infection.
Subjects who have malignant tumors or have a history of malignant tumors.
Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event thatrequired hospitalization within the previous 12 months.
There are serious abnormalities in the cardiovascular, mental, renal, liver, immune,gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrineor hematological systems.
Pregnant women, lactating women, or female participants who plan to become pregnantduring the study period.
Those who are known to be allergic to the test drug or any component of the testdrug.
Study Design
Connect with a study center
Dermatology Hospital affiliated to Shandong First Medical University
Jinan 1805753, Shandong 1796328 250022
ChinaActive - Recruiting

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