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 range18 Years

SexFEMALE

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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;
✕. 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;

What they're measuring

Assessment of change in Target Area Hair Counts

Timeframe: 24 weeks

Trial details

NCT IDNCT06409650

SponsorSuzhou Koshine Biomedica, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-10

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