None listed
Conditions
Interventions
Medical Device :
Subjects use HM-SC-10 or Sham device once a day for 24 weeks.
Sponsors
Huons Meditech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject who understands the research and voluntarily prepares and signs a consent form to participate in clinical trials. 2. Subject who ages 19~65 male or female 3. Subject who is diagnosed Androgenetic Alopecia as below; 1) Male : Norwood-Hamilton Classification IIa~V 2) Female : Ludwig Classification I, II 3) Basic and Specific (BASP) specific type V1, V2, F1, FE 4. Fitzpatric skin type I~IV 5. Subject who do not use of product and Hair care for Alopecia during study period 6. Subject who can remains hair shape and color 7. Subject who agree to cut of hair on measurement area by 3mm
Exclusion criteria
Exclusion criteria: 1. Medical history 1) Subject who has any other alopecia disease (alopecia areata. elogen alopecia,icatricial alopecia etc.) 2) Subject who has Keloid history and slow wound healing 3) Subject who has photosensitivity 4) Subject who has injury on scalp and scalp diseases such as Seborrheic dermatiti, scalp psoria, scalp infection 5) Subject who has tatoo or mark of hair dye on scalp 6) Subject who has undergone surgical treatment such as hair transplantation, hair weave, scalp reduction 7) Subject who was diagnosed malignant tumor 8) Subject who has experience in radiation therapy and chemotherapy 9) Subject who has medical condition that can effect hair grow and alopecia or was diagnosed thyroid diseases(hyperthyroid, hypothyroidism) 10) Subject who has human immunodeficiency virus 11) Subject who has implanted a pacemaker, defibrillator or other active device 12) Subject who has psychological disease according to PI decision or can effect the prticipation of clinical study such as history of drug abuse 13) Subject who excessiv drinking and smoking(over 25 cigarrets) within 1 years at screening 2. Prohibited Drugs and Treatments 1) Subject who has taken or applied the Phytotherapy within 8 weeks at screening 2) Subject who has taken or applied drug which can effect hair growth and alopecia within 1 year at screening 3) Subject who has taken Isotretioin within 1 years at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of hair count at 24 weeks after use of ID | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of hair count at 8, 16 weeks after use of ID;Change of average hair thickness at 8, 16, 24 weeks after use of ID;Change of GPA assessment at 8, 16, 24 weeks after use of ID;Change of Investigator's IGA assessment at 8, 16, 24 weeks after use of ID;Change of subject's satisfiction(VAS) at 8, 16, 24 weeks after use of ID | — |
Countries
Korea, Republic of
Contacts
Public ContactJeehyun Jang
Chung-Ang Univerisity Hospital
Outcome results
None listed