UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059262 |
|---|---|
| Receipt number | R000067760 |
| Scientific Title | Efficacy of 12-week continuous application lipids derived from animal at two dosage levels on scalp barrier function: a randomized, single-blind trial |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/09/30 18:21:56 |
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Basic information
Public title
Efficacy of 12-week continuous application lipids derived from animal at two dosage levels on scalp barrier function
Acronym
Efficacy of 12-week continuous application lipids derived from animal at two dosage levels on scalp barrier function
Scientific Title
Efficacy of 12-week continuous application lipids derived from animal at two dosage levels on scalp barrier function: a randomized, single-blind trial
Scientific Title:Acronym
Efficacy of 12-week continuous application lipids derived from animal at two dosage levels on scalp barrier function
Region
| Japan |
Condition
Condition
no
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of 12-week application of the test sample on scalp barrier function and subjective questionnaire assessments related to scalp dryness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of changes in TEWL across subjects at each assessment week
Key secondary outcomes
Comparison of actual TEWL measurements among individual subjects at each assessment week
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Duration: one week
0.001% lipids derived from animal Solution
Interventions/Control_2
Duration: one week
0.01% lipids derived from animal solution
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who are concerned about scalp dryness in daily life
Key exclusion criteria
1. Individuals currently receiving medication or outpatient treatment for any serious medical condition
2. Individuals who are undergoing exercise or alimentary therapy under medical supervision
3. Individuals with skin or scalp conditions, including atopic dermatitis, contact dermatitis, skin hypersensitivity, or scalp redness and itchiness
4. Individuals with allergic diseases, including egg allergy
5. Individuals with extremely irregular lifestyle habits, such as diet or sleep
6. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamashita |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49, Goryo Ohara, Nishikyo-ku, Kyoto, Japan
TEL
075-748-9829
Kayoko-yamaguchi@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49, Goryo Ohara, Nishikyo-ku, Kyoto, Japan
TEL
075-748-9829
Homepage URL
Kayoko-yamaguchi@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International 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
The ethical committee of the Shiba Palace Clinic
Address
6F Daiwa A Hamamatsucho, 1-9-10 Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1590
jimukyoku@mail.soken-r.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
株式会社ファーマフーズ
Pharma Foods International Co., Ltd. (Kyoto, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067760
