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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031358
Receipt No. R000035796
Scientific Title Investigation of the efficacy of topical anti-fungals to autoimmune vitiligo
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/18

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Basic information
Public title Investigation of the efficacy of topical anti-fungals to autoimmune vitiligo
Acronym Efficacy of topical anti-fungals to autoimmune vitiligo
Scientific Title Investigation of the efficacy of topical anti-fungals to autoimmune vitiligo
Scientific Title:Acronym Efficacy of topical anti-fungals to autoimmune vitiligo
Region
Japan

Condition
Condition Autoimmune vitiligo
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Autoimmune vitiligo is a recalcitrant pigmentary skin disease targeting skin melanocytes. It appears as multiple white patches on the skin and white hair. The efficacy of current treatment option is not satisfactory, thereby more effective treatment modality is desired.
According to recent genetic studies, individuals with high risk for vitiligo have increased susceptibility for microbial stimulation such as S. epidermidis or C. Albicans. These microbial stimulation may cause excessive immune response and eventually lead to autoimmune reaction to melanocytes. The aim of this study is to evaluate the efficacy of topical anti-fungals to autoimmune vitiligo.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate the efficacy of topical anti-fungals by observing the clinical re-pigmentation of vitiligo lesion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Application of topical anti-fungals
Interventions/Control_2
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
1 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are using topical anti-fungals to treat cutaneous fungal infections including tinea pedis or tinea versicolor in Yamagata University hospital Department of Dermatology. Those who understand and agree with this project are enrolled.
Key exclusion criteria Patients who do not agree with our project.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hayashi
Organization Yamagata University Faculty of Medicine
Division name Department of Dermatology
Zip code
Address 2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan
TEL 023-628-5361
Email czk11223@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Hayashi
Organization Yamagata University Faculty of Medicine
Division name Department of Dermatology
Zip code
Address 2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan
TEL 023-628-5361
Homepage URL
Email czk11223@nifty.ne.jp

Sponsor
Institute Yamagata University Faculty of Medicine
Institute
Department

Funding Source
Organization Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 05 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
2018 Year 02 Month 18 Day
Last modified on
2018 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035796

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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