UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030316 |
|---|---|
| Receipt number | R000034474 |
| Scientific Title | investigator initiated study of long-term treatment of Rhododenol-induced Leukoderma with Bimaprost |
| Date of disclosure of the study information | 2017/12/12 |
| Last modified on | 2019/03/12 11:50:22 |
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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
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
watanabe@med.teikyo-u.ac.jp
Public contact
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
tada@df6.so-net.ne.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034474
