JRCT ID: jRCTs051240303
Registered date:26/03/2025
EVERIMEN Study
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | androgenetic alopecia |
| Date of first enrollment | 06/06/2025 |
| Target sample size | 10 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | The investigational drug Stemsap-A will be administered via intradermal injection into the scalp dermis. This will be performed a total of 8 times at 4-week intervals. |
Outcome(s)
| Primary Outcome | Change in scalp hair density from baseline to 32 weeks of treatment (strands/cm2) |
|---|---|
| Secondary Outcome | 1) Changes in scalp hair density (strands/cm2) 2) Modified Global Photographic Assessment (MGPA) score at 16, 32 and 52 weeks post-treatment 3) Changes in Dermatology Life Quality Index (DLQI) 4) Subject satisfaction with treatment at 32 and 52 weeks |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male |
| Include criteria | 1) Patients diagnosed with androgenetic alopecia in males 2) Patients diagnosed with Hamilton-Norwood classification type II Vertex, III Vertex, IV, and V 3) Patients who have used minoxidil, 5-alpha reductase inhibitors, or both in the past (including ongoing use) but are dissatisfied with the results and wish to receive stem cell supernatant fluid 4) Patients aged 18 years or older 5) Patients who have given written informed consent |
| Exclude criteria | 1) Patients undergoing treatment for malignant tumours 2) Patients with concurrent hair loss other than androgenetic alopecia 3) Patients who have previously undergone stem cell supernatant solution treatment for the scalp 4) Patients who have started or changed their treatment for androgenetic alopecia within 6 months prior to obtaining consent 5) Patients currently participating in another clinical trial 6) Patients deemed inappropriate as subjects by the principal investigator (subinvestigator) |
Related Information
| Primary Sponsor | Nakayama Hiroyuki |
|---|---|
| Secondary Sponsor | Takeuchi Jiro |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Hiroyuki Nakayama |
| Address | KOWA Higashinotoin Bldg. 1F, 275-1 Ogisakayacho, Ayanokoji-sagaru, Higashinotoin-dori, Shimogyo-ku, Kyoto-shi, Kyoto Kyoto Japan 600-8095 |
| Telephone | +81-75-754-8852 |
| info@elulaclinic.com | |
| Affiliation | ELULA CLINIC |
| Scientific contact | |
| Name | Hiroyuki Nakayama |
| Address | KOWA Higashinotoin Bldg. 1F, 275-1 Ogisakayacho, Ayanokoji-sagaru, Higashinotoin-dori, Shimogyo-ku, Kyoto-shi, Kyoto Kyoto Japan 600-8095 |
| Telephone | +81-75-754-8852 |
| info@elulaclinic.com | |
| Affiliation | ELULA CLINIC |