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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).

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). - Double-blind, placebo-controlled comparison clinical study of devices PAP-CR-001 for person of premature alopecia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020847
Enrollment
100
Registered
2016-02-02
Start date
2014-05-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature alopecia

Interventions

clinical study of devices:for 24 weeks for 20 minutes a day sham device-for 24 weeks for 20 minutes a day

Sponsors

Shiba Palace Clinic
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: remature alopecia 1 Japanese male over 20 years old 2 A person who judges himself not other alopecia but premature alopecia by the check list of this clinical study examinee, and is conscious that his hair loss pattern corresponds to 2 vertex type, 3 vertex type, 4 type or 5 type by a classification of Takasima 3 A person who is able to agree with maintaining hairdressing, hair coloring and other hair conditions constantly in each visit 4 A person who is able to agree with cutting his hair to 0.5mm length at two ranges of 1.5cm 1.5cm of the neighborhood of balding part of top of head in each visit 5 A person who joins this clinical study in free will and submitted written informed consent

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKo MASUDA

SOUKEN Co., Ltd Management Division

k_masuda@mail.souken-r.com03-5408-1555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026