UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031358
Receipt number 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 2020/08/21 17:08:34

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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 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 or person

Institute

Yamagata University Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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