Double-blind, placebo-controlled comparison clinical study of safety and efficacy of irradiation of clinical study device "PAP-CR-001" for 24 weeks for 20 minutes a day on person of premature alopecia (male pattern baldness).
- Conditions
- Premature alopecia
- Registration Number
- JPRN-UMIN000020847
- Lead Sponsor
- Shiba Palace Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 100
Not provided
Exclusion criteria The person who conflict with any of the following criteria is excluded in this clinical study 1 A person with other diseases of scalp atopic dermatitis, eczema capitis seborrheic dermatitis, psoriasis tinea capitis or other scalp infectious diseases 2 A person who has a medical history of photosensitivity disorder 3 A person who is or will be treated with cancer chemotherapy or the radiotherapy to the head within 6 months before this clinical study or 2 months after this study 4 A person who is alcohol dependencehabitual drinking with no medical management, or severe mental disorder 5 A person who uses a wig regularly or made hair implant or hair augmenting, or who plans these during clinical study period 6 A person who receives scalp massage during clinical examination period 7 A person who used drugs or received treatments regulated by incompatible drug and treatment list in prohibition period before screening 8 A person who joined or will join clinical study of medicine, quasi drugs and medical equipment within 6 months before this clinical study or during this study 9 A person of the aphakia 10 A person whose hair of balding part is with much gray hair in uncolored condition, or changed color by decoloration 11A person of the short hair under 3cm 12 A person who permed his hair within 3 months 90 daysbefore beginning of clinical study medicine administration 13 A person who is judged inappropriate to join the study by doctor in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement evaluation(final evaluation) based on comparison of hair photo of balding part of top of head from a baseline to evaluation time by efficacy evaluation committee or medical specialist
- Secondary Outcome Measures
Name Time Method