UMIN-CTR Clinical Trial

Public title

A clinical trial of the effects and safety of ra76 cream on remission maintenance of atopic dermatitis.

Acronym

A clinical trial of the effects and safety of ra76 cream on remission maintenance of atopic dermatitis.

Scientific Title

A clinical trial of the effects and safety of ra76 cream on remission maintenance of atopic dermatitis.

Scientific Title:Acronym

A clinical trial of the effects and safety of ra76 cream on remission maintenance of atopic dermatitis.

Region

Japan

Condition

Atopic dermatitis

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the clinical efficacy and safety of ra76 cream on remission maintenance of atopic dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The period of the remission maintenance of atopic dermatitis in ra76 cream or active comparator applying term.

Key secondary outcomes

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Pseudo-randomization

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Washout for 1week -> Applying a topical steroid twice a day for 2 weeks -> Applying ra76 cream twice a day for 4 weeks (In case of disease progression, it is allowed to apply a topical steroid in combination under the assessment of the principal investigator)

Interventions/Control_2

Washout for 1week -> Applying a topical steroid twice a day for 2 weeks -> Applying active comparator twice a day for 4 weeks (In case of disease progression, it is allowed to apply a topical steroid in combination under the assessment of the principal investigator)

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

49

years-old

>=

Gender

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.

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

18

Name of lead principal investigator

1st name
Middle name
Last name	Masatoshi Abe

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

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

Institute

Exam CO.,LTD

Institute

Department

Personal name

Organization

Kao Corporation

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

株式会社エクサムデルマラボ（北海道）

Date of disclosure of the study information

2017

Year

01

Month

20

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

2016

Year

12

Month

27

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

18

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=R000029597