UMIN-CTR Clinical Trial

Basic information
Public title	Effects of honeybee products for Skin Conditions: study 2
Acronym	Effects of honeybee products for Skin Conditions: study 2
Scientific Title	Effects of honeybee products for Skin Conditions: study 2
Scientific Title:Acronym	Effects of honeybee products for Skin Conditions: study 2
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of honeybee products for Skin Conditions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	skin moisture content
Key secondary outcomes	1)Indexes for skin conditions (Transepidermal water loss, skin viscoelasticity, the surface texture, visual evaluation) 2)Skin questionnaire (Visual Analogue Scale) 3)Safety evaluation (Doctor's questions)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Apply test cosmetics (lotion) to the designated left or right half face during 4 weeks.
Interventions/Control_2	Apply placebo cosmetics (lotion) to the designated left or right half face during 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	30 years-old <=
Age-upper limit	59 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese males and females aged 30-59 years. 2) Subjects with water content value of 25-40 on both cheeks. 3) Subjects can understand and comply with the rules written in protocol during clinical study period. 4) Subjects whose written informed consent has been obtained. 5) Subjects judged appropriate for the study by the principal.
Key exclusion criteria	The following exclusion criteria apply to subjects. 1) Constantly use cosmetic that contain the ingredient involved in this study. 2) With any allergies. 3) Visit dermatology department(for the purpose of treating atopic dermatitis etc.). 4) With strange skin conditions at measurement points. 5) Conducting hormone replacement therapy. 6) Have ave got cosmetic surgery which would affect the targeted skin. 7) Will get sunburned during the test period. 8) Will receive special treatment (facial esthetics, epilation etc.) during the test period. 9) Can not continue regular life. 10) Have an irregular habit because of working at night or working under work-shift form. 11) Drinks more than 500 ml beer daily. 12) A smoker. 13) Participated in other clinical trial within last 3 months. 14) Working at the health food, cosmetics or pharmaceutical company. 15) Judged not appropriate by principal.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kayoko Middle name Last name Numano
Organization	Numano Clinic
Division name	Not applicable
Zip code	370-0815
Address	15 Yanagawacho, Takasaki-shi, Gunma 370-0815 Japan
TEL	027-322-2926
Email	sakurai@inforward.co.jp

Public contact
Name of contact person	1st name Chizuru Middle name Last name Homma
Organization	Yamada Bee Company, Inc.
Division name	Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code	708-0393
Address	194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL	0868-54-3825
Homepage URL
Email	ch1644@yamada-bee.com

Sponsor
Institute	Yamada Bee Company, Inc.
Institute
Department

Funding Source
Organization	Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	General Incorporated Association Clinical Research Review Centers
Address	2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel	090-3547-6398
Email	crrctakashima@kpd.biglobe.ne.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	2020 Year 10 Month 01 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	35
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	2020 Year 03 Month 04 Day
Date of IRB	2020 Year 09 Month 02 Day
Anticipated trial start date	2020 Year 09 Month 27 Day
Last follow-up date	2020 Year 11 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 11 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045366