A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata (NCT04445363) | Clinical Trial Compass
UnknownPhase 1/2
A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata
China160 participantsStarted 2020-08-12
Plain-language summary
This study includes a dose escalation part(phase I) and a dose extension part(phase II).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)