UMIN-CTR Clinical Trial

Basic information
Public title	investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost
Acronym	investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost
Scientific Title	investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost
Scientific Title:Acronym	investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost
Region	Japan

Condition
Condition	Rhododenol-induced Leukoderma
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Explore the efficacy and safety of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Degree of pigmentation after twelve months application of Bimatoprost on target region.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Bimatoprost would be applied on the target region. The number of times to apply on the skin would follow the same number of times at the end of previous study "investigator initiated study of Rhododenol-induced Leukoderma".
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed as Rhododenol-induced Leukoderma according to diagnostic criteria of Japanese Dermatology Association (meeting all contents of essential diagnostic criteria and meeting at least one content of minor diagnostic criteria) a) essential diagnostic criteria i) Used Rhododenol containing cosmetics ii) Not having Leukoderma before using Rhododenol containing cosmetics. Complete or incomplete depigmented area emerged after use of Rhododenol containing cosmetics on mostly Rhododenol applied area. b) Minor diagnostic criteria i) The enlargement of Leukoderma stopped within a month after withdrawal of Rhododenol containing cosmetics. ii) After withdrawal of Rhododenol containing cosmetics, at least part of Leukoderma became re-pigmented. 2) The participant of the previous study and who also completed the observation period. 3) From the point of view of the efficacy and safety, those who were considered resonable by pricipal investigator or sub-investigator to be included in the subsequent study. 4) Those subjects who want to participate in the subsequent study after completing the previous study. 5) All participants are fully explained about the aim, content and expected side effects of the study. After confirming the participants' understanding, written informed consent is taken under their free will.
Key exclusion criteria	1) Age under twenty years old at the time of inforomed consent. 2) Those who were suspected of concomitant vitiligo vulgaris. 3) Those who show skin problems such as erythema at the site of target region. 4) Those subjects who were considered by the principal investigator or sub-investigator to be showing skin problem which might be related to previous study. 5) Those subjects who were considered by the principal investigator or sub-investigator to be difficult to comply with compliance. 6) Those who show allagic reaction against Bimatoprost. 7) Those women who are pregnant or possibly pregnant or during lactation or those who cannot agree with contraception during the study. 8) Those otherwise principal physician considered unsuitable to include in this study.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shinichi Watanabe
Organization	Teikyo University
Division name	Institute of Medical Mycology
Zip code
Address	359 Otsuka, Hachioji, Tokyo 192-0395 JAPAN 192-0395, Japan
TEL	042-678-3256
Email	watanabe@med.teikyo-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yayoi tada
Organization	Teikyo University School of Medicine
Division name	Department of Dermatology
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8601, Japan
TEL	03-3964-1211
Homepage URL
Email	tada@df6.so-net.ne.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Kanebo Cosmetics Inc
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
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	帝京大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 12 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	2017 Year 11 Month 21 Day
Date of IRB	2017 Year 11 Month 17 Day
Anticipated trial start date	2017 Year 12 Month 15 Day
Last follow-up date	2019 Year 01 Month 29 Day
Date of closure to data entry	2019 Year 01 Month 29 Day
Date trial data considered complete	2019 Year 01 Month 29 Day
Date analysis concluded	2019 Year 01 Month 29 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 08 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034474