UMIN-CTR Clinical Trial

Basic information
Public title	An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Acronym	An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Scientific Title	An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Scientific Title:Acronym	An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Region	Japan

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

Objectives
Narrative objectives1	To verify the improvement in skin lifting with the test food in Japanese adult women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The ratio of the long axis of an ellipse of the stamps of lying down position and standing position * Put a stamp on the cheek at lying down position and standing position, and evaluate the long axis of an ellipse of the stamps of both positions * Assess the measured value at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change.
Key secondary outcomes	1. The difference of the long axis of an ellipse of the stamps between lying down position and standing position 2. Moisture of the skin 3. Transepidermal Water Loss (TEWL) 4. Viscoelasticity of the skin 5. Facial pigmentations 6. Wrinkles on facial skin 7. Facial skin texture 8. Facial pores 9. Facial skin tone 10. Facial redness 11. Measure lift up the skin (3D) 12. Measure the dermis 13. Questionnaire (the Likert scale) *1-13 Assess the measured value at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Capsule containing salmon nasal cartilage-derived proteoglycan Administration: Take one capsule after dinner with water * Daily dose should be taken within the day. If you forget to take the capsule, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 12 weeks Test food: Placebo capsule Administration: Take one capsule after dinner with water * Daily dose should be taken within the day. If you forget to take the capsule, take it 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	Female
Key inclusion criteria	1. Healthy Japanese adult women 2. Subjects who are experiencing sagging the skin 3. Subjects who are judged as eligible to participate in the study by the dermatologist 4. Subjects whose ratio of the long axis of an ellipse of the stamps of lying down position and standing position are relatively large
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 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 are currently taking medications (including herbal medicines) and dietary supplements, particularly allergic to salmon 9. Subjects who are allergy to medications and/or products that contain the study ingredients. Particularly, salmon allergy 10. Subjects who are pregnant, breast-feeding, or planning to become pregnant 11. Subjects who have been participated in another clinical study within the last three months prior to signing informed consent for the current study 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal dermatologist
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code
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 Middle name Last name Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code
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	NIHON PHARMACEUTICAL 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
Address
Tel
Email

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) 医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 05 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
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	2018 Year 11 Month 12 Day
Date of IRB	2018 Year 11 Month 12 Day
Anticipated trial start date	2018 Year 12 Month 05 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 05 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040060