UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030829
Receipt number R000035147
Scientific Title Evaluation of the efficacy of a skin moisturizer on mild to moderate atopic dermatitis
Date of disclosure of the study information 2018/01/18
Last modified on 2019/03/20 08:45:38

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Basic information

Public title

Evaluation of the efficacy of a skin moisturizer on mild to moderate atopic dermatitis

Acronym

Efficacy of a skin moisturizer on atopic dermatitis

Scientific Title

Evaluation of the efficacy of a skin moisturizer on mild to moderate atopic dermatitis

Scientific Title:Acronym

Efficacy of a skin moisturizer on atopic dermatitis

Region

Japan


Condition

Condition

Atopic dermatitis

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of a new skin moisturizer on atopic dermatitis patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical scores assessed by severity classification of atopic dermatitis developed by the advisory committee of atopic dermatitis severity classification of Japanese Dermatological Association at the test site.

Key secondary outcomes

1) Score of skin symptoms
2) Water content
3) Trans-epidermal water loss
4) VAS
5) Skindex-16


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

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply about 1.25 g, 2.5 FTU, of the test moisturizer for face and neck skin twice a day for approximate four weeks. Apply about 2 g, 4 FTU, of the test or control moisturizer for right or left upper extremity skin twice a day for approximate four weeks, respectively.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Adults who live in the suburbs of Tokyo
2)Adults who understand Japanese Language
3)Atopic dermatitis patients with mild to moderate severity on upper extremity, face, and neck.

Key exclusion criteria

1)Atopic dermatitis patients with severe severity on upper extremity, face, and neck areas diagnosed by a dermatological doctor.
2)Patients who were diagnosed with atopic dermatitis and treated by a doctor within 3 months.
3)Patients who use medicine at test site and deemed inappropriate to stop using a drug by the principal doctor.
4)People who take part in another tests of monitors about cosmetics, quasi drugs and drug within 3 months.
5)Pregnancies and lactations and lactating women, women less than six months from childbirth.
6)People who were practiced esthetic massage or skin peeling at test area within 2 weeks.
7)People who have tattoo in face or upper extremity area.
8)Dementia patients
9)Pepole who involved in this test.
10)Employee of cosmetics, quasi drugs or drugs company.
11)Subjects deemed inappropriate to participate in this study by a dermatologist.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaizu Kazuhiro

Organization

Kao Corporation

Division name

Skin Care Products Research

Zip code


Address

5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN

TEL

+81-465-34-0559

Email

kazuhiro.kaizu@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Takashima

Organization

INFORWARD inc.

Division name

EBISU Skin research center

Zip code


Address

1-11-2 5F, Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN

TEL

03-5793-8712

Homepage URL


Email

takashima@inforward.co.jp


Sponsor or person

Institute

INFORWARD inc.

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

KU-2017-01-007

Org. issuing International ID_1

Inforward, inc.EBISU skin research center

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

株式会社インフォワード 恵比寿スキンリサーチセンター(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 18 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

2017 Year 12 Month 27 Day

Date of IRB

2017 Year 12 Month 27 Day

Anticipated trial start date

2018 Year 01 Month 19 Day

Last follow-up date

2018 Year 12 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 16 Day

Last modified on

2019 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035147


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name