UMIN-CTR Clinical Trial

Public title

A Study on the dermatological efficacy of physical therapy for healthy skin (2)

Acronym

Efficacy test of physical therapy for skin

Scientific Title

A Study on the dermatological efficacy of physical therapy for healthy skin (2)

Scientific Title:Acronym

Efficacy test of physical therapy for skin

Region

Japan

Condition

Healthy adults

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of the physical therapy on the natural skin color and the sequential reduction of pigmentation induced by UVB irradiation

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

-Change of stratum corneum water content after 1, 5, and 9 weeks intervention.
-Change of trans epidermal water loss after 1, 5, and 9 weeks intervention.
-Change of skin color after 1, 5, and 9 weeks intervention.
-Change of skin viscoelasticity after 1, 5, and 9 weeks intervention.
-Change of skin shape after 1, 5, and 9 weeks intervention.
-Change of vascular function after 1, 5, and 9 weeks intervention.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

1)Irradiation of UVB on inner side of upper arms for two straight days
2)Apply the physical therapy and placebo therapy for 8weeks after 1week from irradiation of UVB. These therapies will take 3hours per one time and be applied 4 times a week.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male

Key inclusion criteria

-Healthy males

Key exclusion criteria

-Subjects with cutaneous symptoms of atopic dermatitis
-Subjects with clinically-significant disorder (wound and eczema etc.) at the test site
- Subjects who suffer from heat urticaria
-Subjects who play outdoor activities with excessive sunburn routinely
-Subjects with excess sunburn at the test site
-Subjects who take daily application of medicine such as hormone preparation and cosmetics, and medicine for melanosis (chloasma, pigmented spots etc.)
-Subjects who see a doctor regularly or had a routine visit to a clinic within the past 1 month for disease (gastrointestinal system, liver, kidney, heart, blood pressure, skin, and physical deconditioning). (Manual therapy, chiropractic and massage are not included)
-Subjects who suffer from disease relevance to vascular function (hypertension, heart disease, diabetes mellitus, Raynaud disease, rosacea, telangiectasia) and severe feeling of cold
-Subjects who had trouble in electrocardiography in the past (abnormal cardiac rhythm)
-Subject who are taking OTC or prescription medicine( ex. hypnotic, anti-allergic agent, hormone preparation, cathartic, intestinal regulator, and others)
-Subjects known or suspected to be drug allergy
-Subjects who habitually take much (over three cups per day) coffee per day
-Subjects who smoke
-Subjects who participated in another clinical study accompanied by topical application of formulations and tape stripping treatment to the site to be studied within the past 1month
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Takatoshi Murase

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code

Address

2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan

TEL

0285-68-7871

Email

murase.takatoshi@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Yoshie Shimotoyodome

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code

Address

2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan

TEL

0285-68-7872

Homepage URL

Email

shimotoyodome.yoshie@kao.co.jp

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社（栃木県）

Date of disclosure of the study information

2016

Year

04

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

04

Month

20

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

09

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

27

Day

Last modified on

2017

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025475