UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020318 |
|---|---|
| Receipt number | 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 09:34:46 |
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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
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
takashima@inforward.co.jp
Sponsor or person
Institute
Inforward, inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023463
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
