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Recruitment status Completed
Unique ID issued by UMIN UMIN000011748
Receipt No. R000013740
Official scientific title of the study Hair growth effect of fragmin / protamine nano particle
Date of disclosure of the study information 2013/09/13
Last modified on 2016/03/30

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Basic information
Official scientific title of the study Hair growth effect of fragmin / protamine nano particle
Title of the study (Brief title) Hair growth effect of fragmin / protamine nano particle
Region
Japan

Condition
Condition alopecia
Classification by specialty
Dermatology Plastic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assume hair growth effect of fragmin protamin nano particle.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hair volume
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 application of fragmin protamin nano particle
Interventions/Control_2 application of Platelet Rich Plasma
Interventions/Control_3 application of fragmin protamin nano particle and Platelet Rich Plasma
Interventions/Control_4 application of fragmin protamin nano particle and bFGF
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria alopecia patient
Key exclusion criteria dermatitis of scalp
Pregnant woman
Subjects whose doctor in charge do not agree to join the trial
Target sample size 30

Research contact person
Name of lead principal investigator Yuki Takabayashi
Organization National Defense Medical College
Division name Department of Plastic surgery
Address 3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL 04-2997-5156
Email drpl002@ndmc.ac.jp

Public contact
Name of contact person Yuki Takabayashi
Organization National Defense Medical College
Division name Department of Plastic surgery
Address 3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL 04-2997-5156
Homepage URL
Email drpl002@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization National Defense Medical College
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2013 Year 09 Month 13 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 09 Month 13 Day
Anticipated trial start date
2013 Year 09 Month 13 Day
Last follow-up date
2015 Year 03 Month 25 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 09 Month 13 Day
Last modified on
2016 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013740


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