UMIN-CTR Clinical Trial

Public title

Clinical study about a skin disorder patient's skin care(2)

Acronym

Clinical study about a skin disorder patient's skin care(2)

Scientific Title

Clinical study about a skin disorder patient's skin care(2)

Scientific Title:Acronym

Clinical study about a skin disorder patient's skin care(2)

Region

Japan

Condition

A disease patient with atopic dermatitis, psoriasis, old human instinct xerosis, drying of the skin such as contact dermatitides and the pigmentation

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

About an unregulated drug developed as a skin care agent for the disease patient with atopic dermatitis, psoriasis, senile xerosis, drying of the skin such as contact dermatitides and the pigmentation, I carry out a 12-week use examination. For these skin disease patients, I confirm whether you can use this study product without skin stimulation safely and confirm the improvement degree of the dry symptom of the skin as a preliminary evaluation for the usefulness evaluation examination (drying of the skin and improvement of the pigmentation symptom) for the many cases that I will plan in future.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

I do the period of service of this study product in all target people with same 12 weeks and, at the time of a start, observe the change of the skin symptom at the time of six weeks later and the end in (12 weeks later). But, in the case of harmful phenomenon expression, I continue observation until the disappearance of the symptom.
In addition, the desired evaluation in this study aims for a "security" evaluation of more than 90% in Clause 11.2. In addition, as spare examination to the examination in many cases on the basis of the safe confirmation in this study, I pass through a class of corners fluid volume in approximately the examination and analyze an epidermis water loss quantity, skin of epidermis fat quantity, cytokine concerned with inflammation such as class of corners TARC, shape of the class of corners cell and skin color.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The use part of this study product assumes it face. I list it in an attached sheet document about the usage of each study product (5 preparation) and the instructions. Twice a day (morning, night:) Apply 2 mg/cm2 (with all faces for two pearl grain sizes) to an aim after bathing in), all faces and a neck; for the significant part of the pigmentation more study product (Clause 0.4:) I apply knob lift white whitening stick). In addition, I do not set it during the wash out period in approximately the examination.

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

Not applicable

Gender

Female

Key inclusion criteria

Among the patients with the symptom of drying of the skin and the pigmentation, I intend for a person meeting the next standard.
･Atopic dermatitis, psoriasis, senile xerosis, drying of the skin such as contact dermatitides and pigmentation
The person who is judged from the person of the disease with the symptom in the treatment of the underlying disease if the use of this study product is useful
･The person who is stable in its symptom of the underlying disease by treatment
･Woman 20 years or older
･The person that a written agreement is provided from the person

Key exclusion criteria

In the case of next, I exclude it from an object.
･Person with the experience that produced the skin symptoms such as contact dermatitides by this study product ingredient and similar ingredient
･Person with the exanthem that is unsuitable for the application of this study product in the application part
･The person who is not stable in its symptom of the underlying disease
･A man and woman younger than 20 years
･The person whom (as a general rule) cannot examine 12 weeks later
･Person of pregnancy and nursing
･In addition, the person that an examination responsibility (allotment) doctor judges the participation in this study to be inappropriate

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Katsuko Kikuchi

Organization

Tohoku University Graduate School of Medicine.

Division name

Department of Dermatology

Zip code

Address

1-1seiryo-cho aoba-ku sendai

TEL

022-717-7271

Email

kkikuchi@med.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Katsuko Kikuchi

Organization

Tohoku University Graduate School of Medicine.

Division name

Department of Dermatology

Zip code

Address

1-1seiryo-cho aoba-ku sendai

TEL

022-717-7271

Homepage URL

Email

kkikuchi@med.tohoku.ac.jp

Institute

Department of Dermatology
Tohoku University Graduate School of Medicine.

Institute

Department

Personal name

Organization

TOKIWA Pharmaceutical Co., Ltd.

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

Date of disclosure of the study information

2014

Year

10

Month

30

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

2014

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

01

Day

Last follow-up date

2015

Year

09

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

10

Month

03

Day

Last modified on

2016

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017830