UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048632 |
|---|---|
| Receipt number | R000055417 |
| Scientific Title | Evaluation of the efficacy and safety of topical cream on the properties of normal human stratum corneum: An exploratory study. |
| Date of disclosure of the study information | 2022/10/10 |
| Last modified on | 2022/08/09 14:17:42 |
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Basic information
Public title
Evaluation of the efficacy and safety of topically applied cream on the properties of human stratum corneum.
Acronym
Evaluation of the efficacy and safety of topically applied cream on the properties of human stratum corneum.
Scientific Title
Evaluation of the efficacy and safety of topical cream on the properties of normal human stratum corneum: An exploratory study.
Scientific Title:Acronym
Evaluation of the efficacy and safety of topical cream on the properties of normal human stratum corneum: An exploratory study.
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of cream applied topically twice a day for 4 weeks on the improvement of human stratum corneum properties and safety will be exploratively investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin color (Lab)
Water content of stratum corneum
Transepidermal water loss
Stratum corneum collection
Skin observation by doctor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The test product, which is dispensed with two pushes, will be applied topically twice a day for 4 weeks.
Interventions/Control_2
Un treated
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
- Healthy adult males between the ages of 25 and 60 years old.
- Subjects who can undergo the designated tests within the study period.
Key exclusion criteria
- Subjects with chronic physical diseases such as diabetes, heart disease, kidney disease or liver dysfunction.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the cosmetic products.
- Subjects who have demonstrated a previous hypersensitivity reaction to adhesive tapes, medical tapes, or rubber.
- Subjects with skin disease such as atopic dermatitis.
- Subjects who have scars, nevus pimentosus, acne, erythema, or telangiectasia at the test sites.
- Subjects who have undergone the plastic surgery at the test sites.
- Subjects with excessively tanned skin at the test sites.
- Subjects who have shaved, epilated, or removed hair from the test sites. for at least one month prior to obtaining consent.
- Subjects who have topically applied drugs regularly at the test sites for at least one month prior to obtaining consent.
- Subjects who have habitually washed their own skin with nylon or other solid materials for at least one month prior to obtaining consent.
- Subjects who have undergone aesthetic plastic surgery such as peeling or laser irradiation at the test sites for at least six months prior to obtaining consent.
- Subjects who are scheduled to receive vaccinations within the study period.
- Subjects who are judged by doctor to be inappropriate for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Syota |
| Middle name | |
| Last name | Shimizu |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Skin Care Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga, Japan
TEL
077-521-8835
Shimizu.Syota@otsuka.jp
Public contact
Name of contact person
| 1st name | Syota |
| Middle name | |
| Last name | Shimizu |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Skin Care Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga, Japan
TEL
077-521-8835
Homepage URL
Shimizu.Syota@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel
03-6717-1499
shimizu_se@otsuka.jp
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
| 2022 | Year | 10 | 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
8
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
| 2022 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055417
