UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043385
Receipt number R000049536
Scientific Title Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis
Date of disclosure of the study information 2021/02/19
Last modified on 2021/05/10 13:57:19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Safety evaluation of novel bath solution

Acronym

Safety evaluation of novel bath solution

Scientific Title

Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis

Scientific Title:Acronym

Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis

Region

Japan


Condition

Condition

Atopic dermatitis, Xerosis and the like with mild to moderate dry skin symptoms

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the safety and usefulness of the test bath solution after use for 4 weeks.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin findings(1) and adverse events(2) : dermatologist examination,questionnaire for skin condition and the impression of test bath solution,recording,daily life
(1) 0 week,2 week,4 week
(2) 2 week,4 week

Key secondary outcomes

Improvement of dryness and desquamation : dermatologist examination,photographic recording
0 week,2 week,4 week


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Use of the test bath solution at least 5 times a week 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

Male and Female

Key inclusion criteria

1. Patients with mild to moderate dry skin symptoms(Atopic dermatitis,Xerosis and the like)
2. Patients with mild to moderate dry skin symptoms at the examination areas
3. Japanese men and women between the ages of 20 and 69
4. Patients giving written informed consent with his or her own will after receiving an adequate information about the test bath solution and aim of this study

Key exclusion criteria

1. Patients with rashes at the examination areas that intervene the evaluation
2. Patients with rosacea-like dermatitis or with steroid skin disease
3. Patients who take or anticipate to take medicines that affect the study such as oral steroids, immunosuppresant
4. Patients who have applied medicine or moisturizing agent over the examination areas
5. Patients who have applied cosmetics or quasi-medicine that have moisturizing effect
6. Pregnant women
7. Lactating women
8. Patients who have experienced severe skin symptoms many times due to the use of cosmetics in the past
9. Patients who are judged as inappropriate by principal investigator or sub-investigator with other reasons

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Takano

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Center for Clinical Pharmacology

Zip code

004-0839

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan

TEL

011-882-0111

Email

takano@ughp-cpc.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Matsuda

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Center for Clinical Pharmacology

Zip code

004-0839

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan

TEL

011-882-0111

Homepage URL


Email

matsuda@ughp-cpc.jp


Sponsor or person

Institute

Medical Corporation Hokubukai Utsukushigaoka Hospital

Institute

Department

Personal name



Funding Source

Organization

Shiseido Japan Co., Ltd.

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

Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

Tel

011-881-0111

Email

matsuda@ughp-cpc.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

2021 Year 02 Month 19 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

2021 Year 02 Month 18 Day

Date of IRB

2021 Year 02 Month 18 Day

Anticipated trial start date

2021 Year 02 Month 22 Day

Last follow-up date

2021 Year 04 Month 07 Day

Date of closure to data entry

2021 Year 04 Month 08 Day

Date trial data considered complete

2021 Year 04 Month 15 Day

Date analysis concluded

2021 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2021 Year 02 Month 19 Day

Last modified on

2021 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049536


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name