UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000036807
Receipt number	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	2022/08/26 08:46:59

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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

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

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

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

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

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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

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

2022 Year 08 Month 26 Day

Link to view the page

Value
https://center6.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