UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031190
Receipt number R000035608
Scientific Title A clinical study of ATP087 cream and ra76 cream on atopic dermatitis.
Date of disclosure of the study information 2018/02/09
Last modified on 2018/11/13 07:26:25

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Basic information

Public title

A clinical study of ATP087 cream and ra76 cream on atopic dermatitis.

Acronym

A clinical study of ATP087 cream and ra76 cream on atopic dermatitis.

Scientific Title

A clinical study of ATP087 cream and ra76 cream on atopic dermatitis.

Scientific Title:Acronym

A clinical study of ATP087 cream and ra76 cream 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 confirm the clinical efficacy and safety of ATP087 cream and ra76 cream on atopic dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Transition of severity classification (simple method) of atopic dermatitis developed by the advisory committee of atopic dermatitis severity classification of Japanese Dermatological Association at test site (both arms).

Key secondary outcomes

1) Transepidermal water loss, water content of the stratum corneum, erythema and pigmentation, and skin surface topography at test site (both arms), etc.
2) Questionnaires for QOL assessment in atopic dermatitis.


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

Medicine

Interventions/Control_1

Washout for 1week -> Applying ATP087 cream and ra76 cream twice a day for 1 weeks -> Applying ra76 cream twice a day for 6 weeks (In case of disease progression, it is allowed to apply ATP087 cream in combination) -> Post-observation period for 4week

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

49 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients with atopic dermatitis.
2) Patients with mild or moderate rash on test site (both arms).
3) Patients who use moisturizer on body including both arms to control atopic dermatitis.

Key exclusion criteria

1) Patients with severe skin disorders on test site (both arms) and deemed inappropriate to participate in this study by the principal investigator or sub-investigators.
2) Patients with any complications which affect the results of this study.
3) Patients who might use any external use medicines, anti-allergy drugs, or immunosuppressants.
4) Patients with a past history of allergy with test drug components.
5) Patients with hemorrhagic disease.
6) Patients with risk of serious disease in an injury.
7) Patients with menopausal trouble or on menopausal hormone therapy
8) Pregnant or lactating patients. Patients with suspicion of pregnancy.
9) Patients deemed inappropriate to participate in this study by the principal investigator or sub-investigators.

Target sample size

23


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatoshi Abe, M.D., Ph.D

Organization

Sapporo Dermatology Clinic

Division name

Deputy Chief of Clinic

Zip code


Address

H&B Plaza Bldg. 5F, 1-1, Minami 3-jo Nishi 2-chome, Chuo-ku, Sapporo, 060-0063, JAPAN

TEL

011-221-8807

Email

m.abe@dermalabo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukiyoshi Katsumata

Organization

Exam CO.,LTD

Division name

DermaLabo

Zip code


Address

Kogin Bldg. 5F, 2, Kita 1-jo Nishi 5-chome, Chuo-ku, Sapporo, 060-0001, JAPAN

TEL

011-205-0781

Homepage URL


Email

katsumata-y@ekusamu.co.jp


Sponsor or person

Institute

Exam CO.,LTD

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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

株式会社エクサムデルマラボ(北海道)


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 09 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

2018 Year 01 Month 30 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 07 Day

Last modified on

2018 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035608


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name