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NCT Number: NCT07618195

Study of EPI-001 in Patients With Androgenetic Alopecia

This is a Phase I/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of EPI-001 in patients with androgenetic alopecia.

In the Phase I portion, a traditional 3+3 dose-escalation design will be used to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EPI-001. Subjects will be followed for up to 24 weeks after administration.

In the Phase IIa portion, subjects will be randomized in a 2:1 ratio to receive either EPI-001 or placebo. Safety and efficacy will be evaluated through hair count assessment, hair diameter measurement, clinical photography, investigator assessment, expert panel assessment, and subject self-assessment during a follow-up period of up to 48 weeks.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location status: Recruiting

Location contact

Beom Joon Kim, MD, PhD.

PRINCIPAL_INVESTIGATOR

Chung-Ang University Hospital

CONTACT

+82-1800-1114

About this study

Androgenetic alopecia (AGA) is one of the most common forms of hair loss in both men and women and is characterized by progressive hair follicle miniaturization associated with androgen sensitivity and genetic predisposition. Current treatment options for AGA are limited and may not provide sufficient therapeutic benefit for all patients.

EPI-001 is an autologous dermal papilla cell therapy intended for the treatment of androgenetic alopecia. This study is designed to evaluate the safety, tolerability, and efficacy of EPI-001 in subjects with androgenetic alopecia.

This study consists of two parts: a Phase I dose-escalation study and a Phase IIa dose-expansion study.

In the Phase I portion, subjects will receive a single administration of EPI-001 using a traditional 3+3 dose-escalation design to evaluate dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD), and establish the recommended Phase 2 dose (RP2D). Subjects will be followed for up to 24 weeks after administration.

In the Phase IIa portion, eligible subjects will be randomized in a 2:1 ratio to receive either EPI-001 at the RP2D or placebo. The study will evaluate efficacy through changes in total hair count and hair diameter, as well as investigator assessment, expert panel assessment based on clinical photographs, and subject self-assessment questionnaires. Subjects will undergo follow-up assessments for up to 48 weeks after administration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

EPI-001

Biological

EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.

Placebo

Other

Placebo control administered by subcutaneous injection to the scalp.

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities

    Time frame: Up to 4 weeks after administration

Secondary outcomes

  1. Incidence of Adverse Events and Local Adverse Events

    Time frame: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration

  2. Number of Participants With Clinically Significant Abnormal Vital Signs

    Time frame: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration

    Clinically significant abnormal vital signs include abnormalities in systolic blood pressure, diastolic blood pressure, pulse rate, and body temperature.

  3. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration

  4. Investigator Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale

    Time frame: Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48

    Investigators assess hair growth improvement by comparing clinical photographs with baseline photographs using a 7-point scale ranging from -3 (greatly decreased) to +3 (greatly increased). Higher scores indicate greater improvement.

  5. Subject Self-Assessment of Hair Growth Improvement Using a 7-Point Questionnaire Scale

    Time frame: Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48

    Participants assess overall hair growth improvement using a questionnaire evaluating whether hair became fuller, reduction in hair shedding, increase in hair thickness, improvement in hair gloss and elasticity, improvement in overall scalp appearance, and increase in hair growth rate. Each item is scored on a 7-point scale ranging from -3 (greatly worsened) to +3 (greatly improved). Higher scores indicate greater perceived improvement.

  6. Change From Baseline in Total Hair Count Assessed by Phototrichogram

    Time frame: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48

    Total hair count is assessed as the number of hairs identified within the target assessment area using phototrichogram imaging. Changes from baseline in total hair count within the target assessment area are evaluated.

  7. Change From Baseline in Mean Hair Diameter Assessed by Phototrichogram

    Time frame: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48

    Mean hair diameter is assessed by measuring hair shaft thickness within the target assessment area using phototrichogram imaging. Changes from baseline in mean hair diameter are evaluated.

  8. Expert Panel Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale

    Time frame: Phase IIa: Weeks 12, 24, 36, and 48

    Expert panel members assess hair growth improvement by comparing clinical photographs with baseline photographs using a 7-point scale ranging from -3 (greatly decreased) to +3 (greatly increased). Higher scores indicate greater improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Epibiotech Clinical Operations

CONTACT

[email protected]

+82-70-4209-0556

Sponsors and collaborators

Lead sponsor

Epibiotech

Industry

Registry information

Official study title

Phase I/IIa Study to Evaluate the Safety, Tolerability, and Efficacy of EPI-001 in Patients With Androgenetic Alopecia

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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