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New treatment option for Androgenetic Alopecia
Official title Study of EPI-001 in Patients With Androgenetic Alopecia
ClinicalTrials.gov ID: NCT07618195
What this study is testing
What is EPI-001?
EPI-001 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for androgenetic alopecia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Male or female people aged 19 years or older
- people diagnosed with androgenetic alopecia
- people willing to maintain the same hairstyle, hair length, and hair color during the study period
- people willing to refrain from prohibited hair-related products or procedures during the study period
- people willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation
You likely can't join if
- people who used prohibited medications or therapies affecting hair growth within the protocol-defined period
- people with scalp diseases or hair disorders other than androgenetic alopecia
- people with autoimmune diseases affecting the scalp or hair
- people with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases
- people positive for HBV, HCV, HIV, or syphilis screening tests
- people with a history of hair transplantation, stem cell therapy, or gene therapy
See the full eligibility criteria
- Male or female people aged 19 years or older
- people diagnosed with androgenetic alopecia
- people willing to maintain the same hairstyle, hair length, and hair color during the study period
- people willing to refrain from prohibited hair-related products or procedures during the study period
- people willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation
- people who voluntarily signed written informed consent
- people who used prohibited medications or therapies affecting hair growth within the protocol-defined period
- people with scalp diseases or hair disorders other than androgenetic alopecia
- people with autoimmune diseases affecting the scalp or hair
- people with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases
- people positive for HBV, HCV, HIV, or syphilis screening tests
- people with a history of hair transplantation, stem cell therapy, or gene therapy
- people with hypersensitivity related to the investigational product or study procedures
- Pregnant or breastfeeding women
- people who participated in another clinical study within the protocol-defined period
- people judged inappropriate for study participation by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.