UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029233 |
|---|---|
| Receipt number | 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 | 2020/03/23 11:53:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kamatsu@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 22 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 21 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.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 |
