UMIN-CTR Clinical Trial

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
Email	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
Email	Shimizu.Syota@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055417