androgenetic alopecia androgenetic alopecia
Conditions
Interventions
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.
Sponsors
Nakayama Hiroyuki
Takeuchi Jiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in scalp hair density from baseline to 32 weeks of treatment (strands/cm2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHiroyuki Nakayama
ELULA CLINIC
Outcome results
None listed