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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025722
Receipt No. R000029597
Scientific Title A clinical trial of the effects and safety of ra76 cream on remission maintenance of atopic dermatitis.
Date of disclosure of the study information 2017/01/20
Last modified on 2018/11/13

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Basic information
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
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 ra76 cream on remission maintenance of atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
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.

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

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
Institute Exam CO.,LTD
Institute
Department

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
2017 Year 01 Month 20 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
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
Other related information

Management information
Registered date
2017 Year 01 Month 18 Day
Last modified on
2018 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029597

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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