UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049996 |
|---|---|
| Receipt number | R000056942 |
| Scientific Title | Evaluate hair growth effect by long-term use of study sample |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/07/12 14:17:21 |
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Basic information
Public title
Hair growth trial
Acronym
Hair growth trial
Scientific Title
Evaluate hair growth effect by long-term use of study sample
Scientific Title:Acronym
Hair growth trial
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the hair growth effect of the study sample in healthy adult women who are worried about thinning hair in an 18-week repeated dose topical administration study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Photo Trichogram (Hair number, Hair growth rate, Hair diameter, Anagen hair percentage)
Key secondary outcomes
Photography of area at top of head and investigation of adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The study sample is applied twice daily to the scalp in prescribed amounts for 18 weeks.
Interventions/Control_2
Placebo is applied twice daily to the scalp in prescribed amounts for 18 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy Japanese females aged 40 to 69 at the time of informed consent
2. Subjects who is worried about thinning hair and hair loss
3. Subjects who agree to keep the conditions such as hair conditioning and hair dyeing constant on each visiting day
4. Subjects who agree to cut hair locally approximately 1.0 cm x 1.0 cm near the crown on each visiting day
5. Subjects who have signed a consent at own discretion before the start of the study
Key exclusion criteria
1. Subjects with pathological hair loss such as alopecia areata
2. Subjects with scalp diseases other than hair loss (eg, head eczema, seborrheic eczema, psoriasis, tinea capitis, and other scalp infections)
3. Subjects who regularly apply external application or take oral medicines, supplements, etc. that may affect the condition of the head
4. Subjects with a history of hypersensitivity (allergies) to hair growth agents, hair restorer, cosmetics (shampoo, etc.), or hypersensitivity to other medicines.
5. Subjects who have used existing hair growth agents and hair restorer within the past 2 months, regardless of whether they are pharmaceutical products or quasi-drugs.
6. Subjects who regularly use wigs during the study period, subjects who have undergone hair transplantation or hair growth, or subjects who are scheduled during the study period
7. Subjects currently using medications known to cause trichotillomania or hirsutism (eg, phenytoin for epilepsy)
8. Subjects undergoing hormone replacement therapy or taking oral contraceptives
9. Subjects who are pregnant or lactating, or who intend to become pregnant
10. Subjects who have participated in another clinical study within the past month or those who plan to participate during the study period
11. Subjects judged inappropriate for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Sawamoto |
Organization
Shukugawa Sawamoto Hifuka
Division name
Shukugawa Sawamoto Hifuka
Zip code
662-0977
Address
11-3, Kagura-cho, Nishinomiya City, Hyogo, Japan
TEL
0798-37-1112
sawamoto0908@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Taniguchi |
Organization
R&D Center, Nikko Chemicals Co., Ltd.
Division name
under constraction
Zip code
541-0052
Address
1-6-14 Azuchimachi,Chuo-ku,Osaka City, Osaka, Japan
TEL
080-4249-0198
Homepage URL
volunteer@nikkolgroup.com
Sponsor or person
Institute
Nikoderm Research Inc.
Institute
Department
Personal name
Funding Source
Organization
Tsuno Rice Fine Chemicals Co., Ltd.
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
under constraction
Address
1-6-14 Azuchimachi,Chuo-ku,Osaka City, Osaka, Japan
Tel
06-6125-3501
myamamura@nikkolgroup.com
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
| 2023 | Year | 01 | Month | 10 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056942
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