EPI-001 for androgenetic alopecia in adults

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 Phase I/IIa study uses a 3+3 dose-escalation to find the maximum tolerated dose and RP2D of EPI-001, followed by a randomized, placebo-controlled expansion to assess safety and early efficacy. Participants receive a single EPI-001 administration (Phase I) and are monitored for up to 24 weeks for safety, then are reassigned to EPI-001 or placebo in a 2:1 ratio with follow-up of up to 48 weeks. Outcomes include changes in total hair count, hair diameter, clinical photographs, investigator and expert panel assessments, and subject-reported measures. The trial targets adults with androgenetic alopecia, aiming to determine whether this autologous cell therapy can promote hair regeneration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female subjects aged 19 years or older
2. Subjects diagnosed with androgenetic alopecia
3. Subjects willing to maintain the same hairstyle, hair length, and hair color during the study period
4. Subjects willing to refrain from prohibited hair-related products or procedures during the study period
5. Subjects willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation
6. Subjects who voluntarily signed written informed consent

Exclusion Criteria:

1. Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period
2. Subjects with scalp diseases or hair disorders other than androgenetic alopecia
3. Subjects with autoimmune diseases affecting the scalp or hair
4. Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases
5. Subjects positive for HBV, HCV, HIV, or syphilis screening tests
6. Subjects with a history of hair transplantation, stem cell therapy, or gene therapy
7. Subjects with hypersensitivity related to the investigational product or study procedures
8. Pregnant or breastfeeding women
9. Subjects who participated in another clinical study within the protocol-defined period
10. Subjects judged inappropriate for study participation by the investigator

Where it's running

• Chung-Ang University Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Epibiotech Clinical Operations
• Email: info@epibiotech.com
• Phone: +82-70-4209-0556

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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.