UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022212 |
|---|---|
| Receipt number | 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 07:27:55 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025586
