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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036807
Receipt No. R000041936
Scientific Title Effects of consumption of elastin peptide from horse on skin elasticity and body shape: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2019/05/21
Last modified on 2019/08/27

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Basic information
Public title Effects of consumption of elastin peptide from horse on skin elasticity and body shape
Acronym Effects of consumption of elastin peptide from horse on skin elasticity and body shape
Scientific Title Effects of consumption of elastin peptide from horse on skin elasticity and body shape: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym Effects of consumption of elastin peptide from horse on skin elasticity and body shape
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 effects of consumption of the test food on body shapes such as face, bust, and hips.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Viscoelasticity of the face

* Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption and calculate the amount of change.
Key secondary outcomes 1. Viscoelasticity of the bust
2. Viscoelasticity of the hip
3. Bust circumference (top and under)
4. The difference circumference between the top bust and the under bust
5. Bust size
6. The height from the ground to top of the bust
7. Hip circumference
8. The height from the ground to top of the hip
9. Waist circumference
10. Waist-to-hip ratio
11. Change of the bust size
12. Intensity
13. Skin Thickness
14. Low Echogenic Band (LEB)
15. Subjective symptoms (The Likert scale method)
16. Facial skin brightness
17. Numbers of facial skin pigmentations [small size, large size (LV 1), large size (LV 2), large size (LV 3)]
18. Areas of facial skin pigmentations [small size, large size (LV 1), large size (LV 2), large size (LV 3)]
19. Numbers of facial pores
20. Numbers of noticeable facial pores
21. Numbers of facial pores with prominent opening
22. Numbers of facial pores with prominent darkening
23. Numbers of facial wrinkles
24. Total length of facial wrinkles
25. Total area of facial wrinkles
26. Facial skin texture
27. Numbers of facial redness (LV 1, LV 2 and LV 3)
28. Total area of facial redness (LV 1, LV 2 and LV 3)
29. Facial skin moisture


*1-14, 16-29 Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption and calculate the amount of change.
*15 Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption.
*11 Measure the length between the center of clavicle and each breast by 3D camera.
*12-14 Measure the dermal condition by DermaLab.
*16-29 Measure the skin condition by skin analysis device.

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: 8 weeks
Test food: Tablets containing elastin peptide from horse
Administration: Take 2 tablets a day after lunch until before bedtime

* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 8 weeks
Test food: Placebo tablets
Administration: Take 2 tablets a day after lunch until before bedtime

* If you forget to take the test food, 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 anxious about facial skin elasticity

3. Subjects who are judged as eligible to participate in the study by the physician

4. Within the subjects who met 1st to 3rd inclusion criteria, select subjects with relatively low score in viscoelasticity of the face.
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any 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 regularly receive skin care treatment (massages etc.) or use beauty products (facial equipment etc.)

8. Subjects who have got cosmetic surgery

9. Subjects who are currently taking medications (including herbal medicines) and supplements

10. Subjects who work late-night shift and the erratic lifestyle

11. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to horse.

12. Subjects who are pregnant, lactation, or planning to become pregnant

13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period

14. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
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 Naoko
Middle name
Last name SUZUKI
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 BIOCON (JAPAN) LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Hiroo Dermatology Clinic & Mentors inc.
Medical Corporation Seishinkai, Takara Clinic
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 info@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)
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
2019 Year 05 Month 21 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 32
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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 13 Day
Date of IRB
2019 Year 05 Month 13 Day
Anticipated trial start date
2019 Year 05 Month 22 Day
Last follow-up date
2019 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 21 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041936

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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