UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical trial of the effects of topical steroid cream (PVA-N11) on atopic dermatitis.
Title of the study (Brief title)	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	Masatoshi Abe
Organization	Sapporo Dermatology Clinic
Division name	Deputy Chief of Clinic
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	Yukiyoshi Katsumata
Organization	Exam CO.,LTD
Division name	DermaLabo
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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