VC005 tablets in teens with severe alopecia areata

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, non-randomized Phase I trial in adolescents aged 12 to under 18 with severe alopecia areata. The study uses a dose-finding approach to characterize pharmacokinetics, safety, and preliminary efficacy of VC005 tablets. Participants receive VC005 tablets and are monitored for safety and changes in hair loss over the specified period. The trial is sponsored by Jiangsu vcare pharmaceutical technology co., LTD and conducted at The Peking University People’s Hospital in Beijing. Enrollment and procedures follow standard ICH-GCP guidelines with informed consent obtained from subjects and their guardians.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The subject fully understands this study and is able to comply with the relevant trial procedures. The subject and their legal guardian voluntarily sign the informed consent form (ICF).
* Age 12 to 18 years inclusive (including 12 years old, excluding 18 years old) at the time of signing the ICF, both genders, with body weight ≥ 40 kg.
* Subjects must meet the diagnostic criteria for alopecia areata (AA) at both screening and baseline visits.

Exclusion Criteria:

* Women who are pregnant or breastfeeding, or subjects who plan to become pregnant or breastfeed during the study period.
* Subjects with a current diagnosis of acute diffuse alopecia areata (AA).
* Subjects with a current diagnosis of other types of alopecia that may interfere with the evaluation of AA, including but not limited to traction alopecia, cicatricial alopecia, telogen effluvium, androgenetic alopecia, syphilitic alopecia, anagen effluvium, folliculotropic mycosis fungoides, or alopecia caused by thyroid disease, etc.
* Subjects with other scalp diseases that may affect the assessment of AA, such as scalp psoriasis, dermatitis, tinea capitis, etc.

Where it's running

• The Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jianzhong Zhang — The Peking University People's Hospital, Beijing, Beijng
• Study coordinator: xiaojuan lai
• Email: lai_xiaojuan@vcarepharmatech.com
• Phone: +8615358160458

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.