UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018384
Receipt number R000021262
Scientific Title Effects of AVGP (Aloe Vera Gel Powder) for Skin Function of Adult Males Exposed by Ultraviolet in Daily Life
Date of disclosure of the study information 2015/07/23
Last modified on 2016/05/10 11:18:30

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Basic information

Public title

Effects of AVGP (Aloe Vera Gel Powder) for Skin Function of Adult Males Exposed by Ultraviolet in Daily Life

Acronym

Effects of AVGP (Aloe Vera Gel Powder) for Skin Function

Scientific Title

Effects of AVGP (Aloe Vera Gel Powder) for Skin Function of Adult Males Exposed by Ultraviolet in Daily Life

Scientific Title:Acronym

Effects of AVGP (Aloe Vera Gel Powder) for Skin Function

Region

Japan


Condition

Condition

Skin function

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate efficacy of AVGP (Aloe Vera Gel Powder) for skin function of healthy adult males exposed by ultraviolet in daily life.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Skin viscoelasticity
[2]Transepidermal water loss
[3]Water content of the skin
[4]Collagen score (measuring with ultrasonic waves)

Key secondary outcomes

[1]Observation for skin condition
[2]Subjective symptom for skin condition


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test product (12 weeks)

Interventions/Control_2

Oral ingestion of the control product (12 weeks)

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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Male

Key inclusion criteria

[1]Healthy Japanese males aged 30-60 years
[2]Individuals who are outside in the daytime for 2-5 hours

Key exclusion criteria

[1]Individuals who use regularly cosmetology or foods affecting to skin condition
[2]Individuals who have skin disease
[3]Individuals whose arm(s) have an abnormality requiring treatment
[4]Individuals who use regularly quasi-drugs, cosmetics, and creams
[5]Individuals who tan regularly at a tanning salon
[6]Individuals who contract allergic disease with sleep deprivation or sleep disorder
[7]Individuals who contract disease affecting to skin condition
[8]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[9]Individuals who is a smoker (smoking over 20 cigarettes/day)
[10]Individuals who contract or have a history of serious skin disease, hepatopathy, kidney damage, heart disease, lung disease, endocrine disease, and metabolic disease
[11]Individuals who have a history of drug allergy or serious food allergy
[12]Individuals who participated in other clinical studies in the past three months
[13]Individuals judged inappropriate for the study by the principal by the results of subject background, physical findings, or medical examination

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Internal Department

Zip code


Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

03-5405-1059

Email

info@tes-h.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyasu Tamura

Organization

TES Holdings Co., Ltd

Division name

Department of Clinical Trial

Zip code


Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL


Email

info@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Morinaga Milk Industry CO., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Dermatology, Wakayama Medical University

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



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 23 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

2015 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 22 Day

Last modified on

2016 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021262


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name