UMIN-CTR Clinical Trial

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 Masahiro Middle name Last name Hayashi
Organization	Yamagata University Faculty of Medicine
Division name	Department of Dermatology
Zip code	9909585
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 Masahiro Middle name Last name Hayashi
Organization	Yamagata University Faculty of Medicine
Division name	Department of Dermatology
Zip code	9909585
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	the Ethical Review Committee of Yamagata University Faculty of Medicine
Address	2-2-2 Iida-Nishi, Yamagata
Tel	023-628-5047
Email	ikekenkyu@jm.kj.yamagata-u.ac.jp

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	2018 Year 02 Month 05 Day
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date	2024 Year 03 Month 31 Day
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	2020 Year 08 Month 21 Day

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