Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT07251595
Eligibility Criteria:
Inclusion Criteria:
1. Sign the informed consent form before the clinical trial.
2. On the day of signing the informed consent form, the age must be between 18 and 75 years old (inclusive), and it can be either male or female.
3. The subjects and their partners had no intention of having children during the study period and within one month after the administration of the drug, did not donate sperm or eggs, and voluntarily adopted effective contraceptive measures. The serum pregnancy test results of the female subjects must be negative and they must not be in the lactation period.
4. During the screening process, it was clinically diagnosed as non-segmental vitiligo.
5. Throughout the entire research process, the participants agreed to stop using all treatments related to vitiligo as well as any cosmetic products with therapeutic effects.
Exclusion Criteria:
1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders.
2. When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair.
3. During the screening period or at the baseline, there were other active skin lesions or skin infections that might interfere with the use of the study drug or the evaluation of the drug's efficacy.
4. Subjects with a history of related infections/communicable diseases or infection/contagion history.
5. Known or suspected history of immunosuppression.
6. Tuberculosis (TB) or latent tuberculosis infection.
7. Positive for human immunodeficiency virus antibody HIV-Ab, positive for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis B virus (HBV) infection.
8. Subjects who have malignant tumors or have a history of malignant tumors.
9. Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event that required hospitalization within the previous 12 months.
10. There are serious abnormalities in the cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine or hematological systems.
11. Pregnant women, lactating women, or female participants who plan to become pregnant during the study period.
12. Those who are known to be allergic to the test drug or any component of the test drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07251595
Study Brief:
Protocol Section:
NCT07251595