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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029233
Receipt No. R000033391
Scientific Title Clinical study on covering treatment of depigmented lesions with fine fibers
Date of disclosure of the study information 2017/09/21
Last modified on 2019/03/26

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Basic information
Public title Clinical study on covering treatment of depigmented lesions with fine fibers
Acronym Fine fibers
Scientific Title Clinical study on covering treatment of depigmented lesions with fine fibers
Scientific Title:Acronym Fine fibers
Region
Japan

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

Objectives
Narrative objectives1 It is becoming clear that sustainability of makeup improves by pasting fine fiber based sheets on makeup. Therefore, we get patients who have Rhododenol-induced Leukoderma to use cover makeup cosmetics and this sheet, and Doctors confirme its safety.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of feeling of use and effect
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Cover makeup cosmetic material is applied, fine fiber is discharged using a special device from above, and it is pasted in a sheet form on the skin. Further, an emulsion is applied on top of it for drying prevention.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1. In participating in this research, patients who gain document consent by their own free will with sufficient understanding after having received sufficient explanation.
2. Patients between the age of 20 and under the age of 85 at the time of consent acquisition.
3. Patients diagnosed with Rododenol-induced depigmenting Leukoderma.
4. Patients with discoloration plaques in the back, forearm or neck.
Key exclusion criteria 1.Patients with other problem than discoloration plaques in the back, forearm or neck.
2. Patients who are involved in other clinical research.
3. Patients who judged that the doctor in charge is inappropriate as the subject
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kayoko
Middle name
Last name Matsunaga
Organization Fujita Health University School of Medicine
Division name Department of Integrative Medical Science for Allergic Disease
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL 0562-93-9441
Email kamatsu@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Kayoko
Middle name
Last name Matsunaga
Organization Fujita Health University School of Medicine
Division name Department of Integrative Medical Science for Allergic Disease
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL 0562-93-9441
Homepage URL
Email kamatsu@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Sapporo Medical University,
Niigata University Medical & Dental Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujita Health University School of Medicine
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
Tel 0562-93-2000
Email f-irb@fujita-hu.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 北海道公立大学法人 札幌医科大学(北海道)、新潟大学医歯学総合病院(新潟県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 21 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 30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 03 Month 26 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 04 Month 08 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2017 Year 09 Month 06 Day
Last follow-up date
2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 21 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033391

Research Plan
Registered date File name
2017/09/21 ファインファイバー研究計画書_変更申請.pdf

Research case data specifications
Registered date File name
2019/03/26 180604_説明同意文書(ファインファイバー)2か月連用版 (1).doc

Research case data
Registered date File name
2019/03/26 ファインファイバー結果まとめ.pptx


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