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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009623
Receipt No. R000011290
Scientific Title Chronotherapy with finasteride in patients with androgenetic alopecia
Date of disclosure of the study information 2012/12/26
Last modified on 2015/06/25

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Basic information
Public title Chronotherapy with finasteride in patients with androgenetic alopecia
Acronym Chronotherapy with finasteride
Scientific Title Chronotherapy with finasteride in patients with androgenetic alopecia
Scientific Title:Acronym Chronotherapy with finasteride
Region
Japan

Condition
Condition androgenetic alopecia
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of chronotherapy with finasteride.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Changes in liver function tests
Changes in prostate-specific antigen level
Key secondary outcomes All laboratory abnormalities
All adverse events
Compliance with treatment
Self-assessment of the drug efficacy against alopecia
Self-assessment of the drug effect on libido

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dosing of finasteride in the morning for 12 months
Interventions/Control_2 Dosing of finasteride in the evening for 12 months
Interventions/Control_3 Dosing of finasteride in the evening for 6 months, and thereafter dosing in the morning for 6 months
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
70 years-old >=
Gender Male
Key inclusion criteria 1) Patients with androgenetic alopecia
2) Patients who have been treated with finasteride (a fixed dosage in the morning) for more than 6 months
3) All concomitant disease are stable
4) Patients who can give written informed consent
Key exclusion criteria 1) Patients with hypersensitivity to the drug contents
2) Female
3) Acute diseases treated with medication(s) during the 1 month
4) Patients who are disqualified by the doctor
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Fujimura
Organization Jichi Medical University
Division name Clinical Pharmacology
Zip code
Address Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL 0285-58-7387
Email akiofuji@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Ando
Organization Jichi Medical University
Division name Clinical Pharmacology
Zip code
Address Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL 0285-58-7388
Homepage URL
Email h-ando@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 佐藤皮フ科クリニック(栃木県)
菅井皮膚科パークサイドクリニック(栃木県)
臼井皮膚科医院(栃木県)
久保川皮膚科医院(栃木県)
高根沢皮フ科クリニック(栃木県)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 26 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
2012 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 12 Month 25 Day
Last modified on
2015 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011290

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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