UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009623 |
|---|---|
| Receipt number | 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 13:37:01 |
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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
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
h-ando@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011290
