UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055691 |
|---|---|
| Receipt number | R000063640 |
| Scientific Title | Skin condition survey and efficacy test of the skin external preparation (BH318) on dry sensitive skin |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2025/11/13 12:05:47 |
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Basic information
Public title
Skin condition survey and efficacy test of the serum on dry sensitive skin
Acronym
Skin condition survey and efficacy test of the serum
Scientific Title
Skin condition survey and efficacy test of the skin external preparation (BH318) on dry sensitive skin
Scientific Title:Acronym
Skin condition survey and efficacy test of the skin external preparation
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the skin condition of dry sensitive skin. Also, to confirm the efficacy of the skin external preparation (BH318) in improving skin properties and its safety.
Basic objectives2
Others
Basic objectives -Others
To understand the skin condition of dry sensitive skin. Also, to confirm the efficacy of the skin external preparation (BH318) in improving skin properties and its safety.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy : Change in desquamation and scaling score based on visual observation by doctor
Safety: Incidence of adverse events
Key secondary outcomes
- Skin capacitance value
-Transdermal water vaporization (TEWL value)
-Skin blood flow
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 skin external preparation (BH318) to the face twice a day for 4wks.
Interventions/Control_2
Apply placebo to the face twice a day for 4wks.
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
Female
Key inclusion criteria
Skin condition survey, efficacy test Common eligibility
1. Japanese women between the ages of 20 and 59
2. Person who are aware of their facial skin type as dry skin.
3. Person who are aware that they have sensitive skin.
4. Person who are relatively simple in their usual care after washing their face.
5. Person who understand the measurement contents and schedule of this research and can follow the various restrictions and instructions given by the researcher during the period of cooperation in participating in the research.
6. Person who are able to obtain written consent based on their own free will prior to the start of the research.
Eligibility for the efficacy test only
1. Top 40 participants in the skin condition survey who have a high desquamation/scaling score based on visual observation by doctor (the score must be 0.5 or higher).
Key exclusion criteria
1. Person who have scars, eczema or other skin problems at the test site
2. Person who have severe itching and redness on the skin of the test site
3. Person who have been diagnosed with skin diseases such as atopic dermatitis or sebum deficiency on the test site and have visited the hospital or used medicines within a year
4. Person who have undergone cosmetic treatment (chemical peeling, laser treatment, etc.) on the test site or have undergone cosmetic treatment (cosmetic surgery, collagen injection, etc.) in the past one year from the time of explanation.
5. Person who are taking sleeping pills, antiallergic drugs, painkillers, hormonal agents, laxatives, gastric acid secretion inhibitors, or other medicines for illnesses on a regular basis.
6. Person who are being treated for diseases that may affect blood flow measurement (hypertension, heart disease, diabetes, Raynaud's disease, rosacea, telangiectasia, etc.)
7. Person who are routinely lose weight or have extremely irregular eating habits.
8. Person with extreme sunburn or person who cannot avoid prolonged outdoor work or sports
9. Person who have a habit of smoking or excessive alcohol consumption.
10. Person who are nursing or pregnant, or who wish to become pregnant during the test period
11. Participants or their family members who are in the following occupations: cosmetics, mass media, research, or clinical trial organization.
12. Person who have participated in a human study within the past 4 weeks.
13. Currently participating in other clinical trials or clinical studies, or planning to participate during the test period.
14. Others who are deemed ineligible by the principal investigator or investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Matsuoka |
Organization
Kao Corporation
Division name
Human Health 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
Human Health 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
| 2024 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
80
Results
Skin survey: Subjects tend to have low moisture content and high skin surface pH. They also reported coarse texture, dullness, and itching in cold/dry conditions.
Efficacy test: The test product significantly increased moisture content in one week and reduced Visioscan SEsc (scaling index). It received high subject ratings and was useful for dry sensitive skin. No intervention-related irritation was observed in physician interviews or subject assessments, confirming safety for dry sensitive skin.
Results date posted
| 2025 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Women in their 20's to 50's
Dry and sensitive skin conscious
Participant flow
1) Skin condition survey (80 patients)
2) Selection of 40 patients with high desquamation/scaling score by visual observation by a doctor
3) Efficacy test for 4 weeks (40 subjects)
Adverse events
None
Outcome measures
Doctor's desquamation/scaling score, moisture content, TEWL, skin surface pH, skin blood flow, Visioscan (texture/scaling), questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association analysis between skin properties and blood flow.
Management information
Registered date
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063640
