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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020847
Receipt No. 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

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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
Email 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
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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