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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020318
Receipt No. R000023463
Scientific Title A study on dosage and administration of the hair growth formula.
Date of disclosure of the study information 2015/12/24
Last modified on 2016/09/28

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Basic information
Public title A study on dosage and administration of the hair growth formula.
Acronym A study on dosage and administration of the hair growth formula.
Scientific Title A study on dosage and administration of the hair growth formula.
Scientific Title:Acronym A study on dosage and administration of the hair growth formula.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the influence of dosage and administration of the hair growth formula on hair growing effect.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hair thickness before and after 6 months application.
Key secondary outcomes Hair density, anagen hair ratio, and an assessment by dermatologist before and after 6 months application.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply the hair growth formula once a day for 6 months.
Interventions/Control_2 Apply the hair growth formula twice a day for 6 months.
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
59 years-old >=
Gender Male
Key inclusion criteria 1) People with subjective symptoms of androgenic alopecia.
2) People who apply to class II vertex to class V by Hamilton-Norwood's classification.
Key exclusion criteria 1) People with alopecia other than androgenic alopecia (alopecia areata, alopecia with thyroid disease, etc.), or with alopecia of unknown origin.
2) People who have sudden hair loss, or macular hair loss.
3) People who have a wide range of wound, rash or inflammation on scalp.
4) People who are using the hair growth formula, or used it within 1 month.
5) People who are using the external medicine on scalp, or used it within 1 month.
6) People who take anti-inflammation, anti-histamine or anti-hormonal medicines.
7) People with experiencing a side effects such as allergy by using the hair growth formula.
8) People with experiencing an allergy by using the medicines or cosmetics.
9) People with experiencing the hair transplant.
10) The length of parietal hair is shorter than 3cm.
11) People with many gray hair.
12) Oneself or the living family work at advertising agency, research or consultant agency, mass media, distribution industry, or industry of cosmetics, foods or toiletry items.
13) People who participate in other clinical trials.
14) People who judged as unsuitable for this study by a principal investigator or sub-investigators.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Takashima
Organization Inforward, inc.
Division name Ebisu Skin Research Center
Zip code
Address 1-11-2-5F, Ebisu, Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL 03-5793-8712
Email takashima@inforward.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Takashima
Organization Inforward, inc.
Division name Ebisu Skin Research Center
Zip code
Address 1-11-2-5F, Ebisu, Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL 03-5793-8712
Homepage URL
Email takashima@inforward.co.jp

Sponsor
Institute Inforward, inc.
Institute
Department

Funding Source
Organization Kao Corporation
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 株式会社インフォワード恵比寿スキンリサーチセンター(東京都)
Ebisu Skin Research Center, Inforward, inc.(Tokyo)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 24 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
2015 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 25 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
2015 Year 12 Month 24 Day
Last modified on
2016 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023463

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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