To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia (NCT06409650) | Clinical Trial Compass
CompletedPhase 2
To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia
China160 participantsStarted 2021-11-09
Plain-language summary
This was a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 Tincture in Chinese adult female subjects with AGA.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study and sign the ICF in writing;
. Female, ≥ 18 years old;
. Clinically diagnosed as androgenetic alopecia;
. Alopecia severity was Ggraded D3-D6 according toon Savin scale;
. Willing to maintain the same hair style, color and length at each follow-up visit;
. Have no pregnancy plan and agree to take highly effective contraceptives throughout the study and within 3 months after the last dose. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug.
Exclusion criteria
. Medical/surgical history of any uncontrolled serious clinical system diseases, which may affect the safety and efficacy evaluation of the study drug, such as circulatory system, nervous system, hematological system, digestive system (e.g., inflammatory bowel disease), immune system, psychiatric disorders, etc.;
. Known hair loss disorders other than AGA, such as alopecia areata or diffuse alopecia areata, syphilitic alopecia, cicatricial alopecia, malnutrition, alopecia due to chemotherapy/radiotherapy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Scalp skin diseases that affect the efficacy evaluation, scalp trauma, or other scalp skin lesions requiring topical drug therapy, such as fungal or bacterial infection, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis and scalp atrophy;
. Concomitant diseases that affect hair growth, such as connective tissue disease, inflammatory bowel disease, moderate to severe anemia and significant short-term weight loss;
. History of hair transplantation or requiring long-term wearing of a wig and hair adhesive during the study treatment;
. Have used topical drugs for hair loss sites (including corticosteroids, estrogens, etc.) that may affect the efficacy evaluation for ≥ 2 consecutive weeks within 3 months prior to screening;
. Have used androgen replacement therapy, immunosuppressants and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
. Have used minoxidil within 6 months prior to screening;