UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038647
Receipt number R000043838
Scientific Title Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study
Date of disclosure of the study information 2019/11/20
Last modified on 2020/06/20 20:29:12

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Basic information

Public title

Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study

Acronym

Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study

Scientific Title

Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study

Scientific Title:Acronym

Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study

Region

Japan


Condition

Condition

non-atopic adults, atopic dermatitis

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In adult volunteers with no history of atopic dermatitis and adult volunteers with a history of atopic dermatitis, the longitudinal changes in the stratum corneum by application of moisturizers will be examined using a confocal Raman spectroscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1. Water content of stratum corneum and specific molecules (natural moisturizing factor, urea, urocanic acid, ceramide, cholesterol, etc.) measured by confocal Raman spectroscopy.

Key secondary outcomes

2. Stratum corneum pH
3. Water content of stratum corneum
4. TEWL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

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

Prevention

Type of intervention

Other

Interventions/Control_1

Apply about 0.5g of Pigeon Baby Cream f on one forearm and Pigeon Vaseline on the other forearm. Apply once a day after bathing and continue daily for 28 days (+7 days) until the end of the third measurement.

Interventions/Control_2

Apply about 0.5g of Pigeon Baby Cream f on the forearm different from Intervention 1 and Pigeon Vaseline on the other forearm. Apply once a day after bathing and continue daily for 28 days (+7 days) until the end of the third measurement.

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

Male and Female

Key inclusion criteria

Those who are 20 years of age or older when obtaining consent

Key exclusion criteria

1) Those who have been diagnosed with allergies to moisturizers
2) Those who have taken steroids or immunosuppressants for one month prior to registration
3) Those who have used topical steroids or tacrolimus for the forearm within one month before registration
4) Participants in other usage tests
5) Those who are determined to be inappropriate for study participation by the study doctor or study director

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Kazue
Middle name
Last name Yoshida

Organization

National Center for Child Health and Development

Division name

Division of Dermatology

Zip code

157-8535

Address

2-10-1, Okura, Setagayaku, Tokyo 157-8535

TEL

03-3416-0181

Email

skin_research@ncchd.go.jp


Public contact

Name of contact person

1st name Naoko
Middle name
Last name Mochimaru

Organization

National Center for Child Health and Development

Division name

Division of Dermatology

Zip code

157-8535

Address

2-10-1, Okura, Setagayaku, Tokyo 157-8535

TEL

03-3416-0181

Homepage URL


Email

skin_research@ncchd.go.jp


Sponsor or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



Funding Source

Organization

Pigeon corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Child Health and Development

Address

2-10-1, Okura, Setagayaku, Tokyo 157-8535

Tel

03-3416-0181

Email

rinri@ncchd.go.jp


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

2019 Year 11 Month 20 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

No longer recruiting

Date of protocol fixation

2019 Year 10 Month 30 Day

Date of IRB

2019 Year 10 Month 08 Day

Anticipated trial start date

2019 Year 11 Month 12 Day

Last follow-up date

2020 Year 03 Month 31 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 11 Month 20 Day

Last modified on

2020 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043838


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name