A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata

Launched by SUZHOU ZELGEN BIOPHARMACEUTICALS CO.,LTD · Jun 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new cream called Jaktinib Hydrochloride, which is applied to the skin, to see if it can help people with a condition called Alopecia Areata (AA). Alopecia Areata causes patches of hair loss, and this study aims to find out how well the cream works and what the best dose is for treating this condition. The trial is currently active but not recruiting new participants.

To be eligible for this study, participants must be between 18 and 65 years old and diagnosed with Alopecia Areata, with hair loss covering 5% to 49% of their scalp for at least six months. Women of childbearing age will need to have negative pregnancy tests and use effective birth control during the study. Participants should be able to commit to treatment for at least six months and attend regular study visits. It's important to note that those with certain other health conditions or specific types of hair loss will not be included in the trial. If you qualify and choose to participate, you will be closely monitored for any side effects and will help researchers learn more about this potential treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 \~ 65 years old (including boundary value), regardless of gender;
• • Diagnosis of Alopecia Areata;
• • Hair loss accounts for 5% \~ 49% of the total scalp area;
• • The duration of hair loss is at least 6 months, the longest is not more than 5 years;
• • Patients can complete treatment for at least 6 months;
• • About Fertility needs meet the following criteria: The results of serum pregnancy tests performed by fertile women during screening visits must be negative, and the results of human chorionic gonadotropin tests performed before the initiation of the study drug must be negative;Women who were fertile and men who had not received vasectomies were required to use effective contraception throughout the study period beginning with the informed consent and up to six months after the last administration;
• • Subjects will voluntarily participate in the study after learning about the content and potential adverse drug reactions and must sign an IRC-approved informed consent prior to beginning any examination required by the study;
• • Subject is willing and able to comply with scheduled visits, treatment plan, study drug administration, and other study procedures.
• Exclusion Criteria:
• • The following causes of hair loss should be excluded: hair loss caused by androgenic alopecia,syphilis, thyroid diseases, etc.
• • Acute Diffuse and Total Alopecia of the Female Scalp;
• • Prior history of serious chronic diseases, such as thyroid disease, liver disease, malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction, tumor and mental illness, etc;
• • Human immunodeficiency virus infection, hepatitis C virus infection, hepatitis B virus infection;
• • Participated in a trial for a topical or oral JAK inhibitor;
• • Allergic reactions to active ingredients or excipients are known or determined by the investigator;
• • Receipt of treatment known to potentially affect the course of AA within last 3 month;
• • In the opinion of the investigator , the subject is inappropriate for entry into this study.