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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035147
Receipt No. R000040060
Official scientific title of the study An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/08

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Basic information
Official scientific title of the study An investigation study for lifting up the skin improvement with ingestion of proteoglycan for 12 weeks on Japanese adult women
Title of the study (Brief title) 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 Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
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 Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 12 Day
Anticipated trial start date
2018 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 08 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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