UMIN-CTR Clinical Trial

Basic information
Public title	The verification study for improving skin conditions: A randomized, placebo-controlled, double-blind, parallel study
Acronym	The verification study for improving skin conditions
Scientific Title	The verification study for improving skin conditions: A randomized, placebo-controlled, double-blind, parallel study
Scientific Title:Acronym	The verification study for improving skin conditions
Region	Japan

Condition
Condition	Healthy Japanese adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of the test food on improving dryness and unpleasantness of skin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Moisture of the skin surface 2. Transepidermal Water Loss (TEWL) *1,2 Assess at 0, 4, and 8 weeks after consuming
Key secondary outcomes	1. Glossiness of the skin surface 2. Viscoelasticity of the skin 3. Skindex-16 4. The Japanese version of Dermatology Life Quality Index (DLQI) 5. Visual Analogue Scale (VAS) of itching sensation 6. Blood test TARC, nonspecific IgE (RIST) *1-6 Assess at 0, 4, and 8 weeks after consuming

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test materials: Acacia bark extracted tablets Administration: Take 6 tablets in the morning with water or warm water * When you have breakfast, take the tablets after breakfast. If you forget to take the tablets, take them as soon as you remember within the day.
Interventions/Control_2	Duration: 8 weeks Test materials: Placebo Administration: Take 6 tablets in the morning with water or warm water * When you have breakfast, take the tablets after breakfast. If you forget to take the tablets, take them as soon as you remember within the day.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese adults who feel discomfort (tickling) with their skin due to drying of their face and/or hands 2. Subjects who are not diagnosed with any skin disease (e.g., atopic dermatitis) and are judged as eligible to participate in the study by the principal investigator. 3. Among the subjects who passed 2., subjects whose TARC level is less than 450 pg/mL and nonspecific IgE level is less than 170 IU/mL 4. Among the subjects who passed 3., subjects whose TEWL is relatively high
Key exclusion criteria	1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Subjects who are diagnosed with restless legs syndrome 5. Subjects who have been diagnosed with atopic dermatitis 6. Subjects who use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare. 7. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 8. Subjects who have been overexposed to the sun within the last month before the agreement to participate in this trial, or are going to overexpose to the sun during this trial (from the agreement to participate in this trial to the final test) 9. Currently taking medicines (include herbal medicines) and supplements 10. Subjects who are allergic to medicines and/or the test food related products or who have allergic skins 11. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 13. Subjects who are judged as ineligible to participate in the study by the principal investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name YAMAMOTO Middle name Last name Kazuo
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	141-0022
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name SUZUKI Middle name Last name Naoko
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	mimozax Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroo Dermatology Clinic & Mentors inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.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	広尾皮フ科クリニック (東京都) Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 12 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	https://www.tandfonline.com/doi/full/10.1080/09168451.2018.1547626?journalCode=tbbb20
Number of participants that the trial has enrolled	66
Results	Hoshino T, Yamashita S, Suzuki N, Baba A, Ogawa S, Izumi T. Impact of Acacia bark extract tablets on the skin of healthy humans: a randomized, double-blind, placebo-controlled study. Biosci Biotechnol Biochem. 2019; 83(3): 538-550
Results date posted	2021 Year 07 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 12 Month 10 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
Date of IRB	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 07 Month 12 Day
Last follow-up date	2017 Year 12 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	2017 Year 07 Month 12 Day
Last modified on	2021 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032254