UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020847 |
|---|---|
| Receipt number | R000016737 |
| Scientific Title | 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). |
| Date of disclosure of the study information | 2016/02/02 |
| Last modified on | 2016/02/02 15:54:38 |
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Basic information
Public title
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).
Acronym
Double-blind, placebo-controlled comparison clinical study of devices PAP-CR-001 for person of premature alopecia.
Scientific Title
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).
Scientific Title:Acronym
Double-blind, placebo-controlled comparison clinical study of devices PAP-CR-001 for person of premature alopecia.
Region
| Japan |
Condition
Condition
Premature alopecia
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine 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).
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
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
clinical study of devices:for 24 weeks for 20 minutes a day
Interventions/Control_2
sham device-for 24 weeks for 20 minutes a day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key 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
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ko MASUDA |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
PANASONIC Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 02 | Day |
Last modified on
| 2016 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016737
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