UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059969 |
|---|---|
| Receipt number | R000068580 |
| Scientific Title | Efficacy test of the topical agent (BH318) for dry skin of the shins |
| Date of disclosure of the study information | 2026/01/11 |
| Last modified on | 2025/12/04 13:03:23 |
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Basic information
Public title
Efficacy test of the body care product for dry skin of the shins
Acronym
Efficacy test of the body care product
Scientific Title
Efficacy test of the topical agent (BH318) for dry skin of the shins
Scientific Title:Acronym
Efficacy test of the topical agent
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the topical agent (BH318) for dry skin of the shins.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in physician-assessed desquamation and scaling scores (by visual inspection)
Key secondary outcomes
- Stratum corneum hydration
- Trans epidermal water loss (TEWL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Apply the topical agent (BH318) to the shins twice daily for 4 weeks.
Interventions/Control_2
Apply placebo to the shins twice daily for 4 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.Japanese women aged 40-69 years
2.Person with dry skin on the shins exhibiting pityriasis like (bran like) scaling.
3.Person who understands the study procedures and schedule and who is willing and able to comply with the restrictions during the study participation period and to follow instructions from the study staff.
Key exclusion criteria
1. Person with eczema, excoriation (scratch marks), contusions (bruises), or other skin lesions at the test site.
2. Person with marked pruritus and erythema at the test site.
3. Person diagnosed with skin diseases affecting the test site (e.g.,atopic dermatitis or asteatotic dermatitis) who has received outpatient treatment or used medication for those conditions within the past year.
4. Person who develops eczema or urticaria in response to heat exposure.
5. Person who has undergone cosmetic/aesthetic procedures at the test site (e.g., esthetic treatments, hair removal, laser therapy) within the past year.
6. Person who is on chronic medication use (e.g., hypnotics, antihistamines, analgesics, hormonal agents, laxatives, acid-suppressing drugs) or who regularly uses other medications for underlying diseases.
7. Person receiving treatment for conditions that may affect blood-flow measurements (e.g., hypertension, heart disease, diabetes, Raynaud's phenomenon, rosacea, telangiectasia).
8. Person who is regularly dieting for weight loss or whose dietary habits are severely irregular.
9. Person with severe sunburn at the test site, or who cannot avoid prolonged outdoor work or sports with the test site exposed.
10. Person who smokes or who habitually consumes excessive amounts of alcohol.
11. Person who is pregnant, breastfeeding, or intends to become pregnant during the study period.
12. Person who, personally or whose family members, are employed in the following fields: cosmetics industry, mass media, research organizations, or clinical trial institutions.
13. Person who has participated in a human clinical study within the past 4 weeks.
14. Person who is currently participating in another clinical trial or who plans to participate in another clinical trial during the study period.
15. Person judged by the principal investigator or study director to be ineligible for this study.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Matsuoka |
Organization
Kao Corporation
Division name
Skin Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7690
matsuoka.megumi@kao.com
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Harada |
Organization
Kao Corporation
Division name
Skin Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7690
Homepage URL
harada.ryouko@kao.com
Sponsor or person
Institute
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2026 | Year | 01 | Month | 11 | 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 | 11 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 04 | 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 | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068580
