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JAPANESE
JRCT ID: jRCTs051240303

Registered date:26/03/2025

EVERIMEN Study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedandrogenetic alopecia
Date of first enrollment06/06/2025
Target sample size10
Countries of recruitment
Study typeInterventional
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 OutcomeChange in scalp hair density from baseline to 32 weeks of treatment (strands/cm2)
Secondary Outcome1) 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 maximumNot applicable
GenderMale
Include criteria1) 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 criteria1) 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

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
E-mail 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
E-mail info@elulaclinic.com
Affiliation ELULA CLINIC