UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the dermatological efficacy and safety of physical therapy for healthy skin
Title of the study (Brief title)	Efficacy test of physical therapy for skin
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the dermatological efficacy and safety of physical therapy for healthy female skin around eye area.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the stratum corneum water content, the transepidermal water loss, the skin color and the dermatological assessment after the single treatment and the repeated treatment for 2 and 4 weeks with the physical therapy.
Key secondary outcomes

Base
Study type	Interventional

Study design
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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the physical therapy and placebo therapy for skin around eye area for 10 minutes once a day for 4 weeks
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Female
Key inclusion criteria	Healthy females
Key exclusion criteria	1.Subjects with atopic dermatitis, eczema and pollen allergy 2.Pregnancies and lactations 3.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Kenji Kabashima
Organization	Graduate School of Medicine, Kyoko University
Division name	Department of Dermatology
Address	54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan 6068507
TEL	075-751-3310
Email	kaba@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Kenji Kabashima
Organization	Graduate School of Medicine, Kyoko University
Division name	Department of Dermatology
Address	54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan 6068507
TEL	075-751-3310
Homepage URL
Email	kaba@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Dermatology, Graduate School of Medicine, Kyoko University
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	京都大学大学院皮膚科（京都府） Department of Dermatology, Graduate School of Medicine, Kyoko University

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 07 Day
Anticipated trial start date	2015 Year 05 Month 25 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	2015 Year 05 Month 20 Day
Last modified on	2016 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020430