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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022212
Receipt No. R000025586
Scientific Title A clinical trial of the effects of topical steroid cream (PVA-N11) on atopic dermatitis.
Date of disclosure of the study information 2016/05/06
Last modified on 2018/11/13

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Basic information
Public title A clinical trial of the effects of topical steroid cream (PVA-N11) on atopic dermatitis.
Acronym A clinical trial of the effects of topical steroid cream (PVA-N11) on atopic dermatitis.
Scientific Title A clinical trial of the effects of topical steroid cream (PVA-N11) on atopic dermatitis.
Scientific Title:Acronym A clinical trial of the effects of topical steroid cream (PVA-N11) on atopic dermatitis.
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the clinical efficacy and safety of topical steroid cream (PVA-N11) in the treatment of atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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) before and after the two-week application.
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) before and after the one- and the two-week application.
2) Questionnaires for QOL assessment in atopic dermatitis before and after the one- and the two-week application, and two weeks after the end of application.

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Apply topical steroid cream (PVA-N11) twice a day for 2 weeks.
Interventions/Control_2 Apply active comparator twice a day for 2 weeks.
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
16 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).
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) Pregnant or lactating patients. Patients with suspicion of pregnancy.
5) Patients deemed inappropriate to participate in this study by the principal investigator or sub-investigators.
Target sample size 36

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
2016 Year 05 Month 06 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 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 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
2016 Year 05 Month 05 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=R000025586

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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