UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053135 |
|---|---|
| Receipt number | R000058042 |
| Scientific Title | Validation of efficiency of the assertive make-up program for women patients to reform their body-image and improve their Quality of Life |
| Date of disclosure of the study information | 2023/12/17 |
| Last modified on | 2023/12/17 16:44:52 |
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Basic information
Public title
Validation of efficiency of the assertive make-up program for women patients to reform their body-image and improve their Quality of Life
Acronym
Validation of efficiency of the assertive make-up program for women patients to reform their body-image and improve their Quality of Life
Scientific Title
Validation of efficiency of the assertive make-up program for women patients to reform their body-image and improve their Quality of Life
Scientific Title:Acronym
Validation of efficiency of the assertive make-up program
Region
| Japan |
Condition
Condition
autoimmune disease, Collagen disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
| Dermatology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The first objective is to evaluate effectiveness of the assertive make-up program for the women patient who has autoimmune disease or dermatological disease to reform their body-image and improve their Quality of Life. The second objective is to evaluate the difference between assertive make-up and aesthetical make-up.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The score of POMS-2, BIAT, SF-8, salivary amylase, and the activity of autonomic nerve
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
assertive make-up therapy
Interventions/Control_2
aesthetical make-up
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
20~65 yeara old female patient with Collagen disease;who are judged to have no problem participating in this study;who understand the purpose of the study and agree to participate in the study
Key exclusion criteria
The patient who can't make-up because of their skin condition is not stable.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Xiaodong |
| Middle name | |
| Last name | Cardenas |
Organization
Japanese Red Cross Toyota College of Nursing
Division name
Faculty of Nursing
Zip code
4718565
Address
12-33 Nanamagari, Hakusann-cho, Toyota, Aichi, Japan
TEL
0565365111
x-cardenas@rctoyota.ac.jp
Public contact
Name of contact person
| 1st name | Xiaodong |
| Middle name | |
| Last name | Cardenas |
Organization
Japanese Red Cross Toyota College of Nursing
Division name
Faculty of Nursing
Zip code
4718565
Address
12-33 Nanamagari, Hakusann-cho, Toyota, Aichi, Japan
TEL
0565365111
Homepage URL
x-cardenas@rctoyota.ac.jp
Sponsor or person
Institute
Japanese Red Cross Toyota College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Toyota College of Nursing
Address
12-33 Nanamagari, Hakusann-cho, Toyota, Aichi, Japan
Tel
0565365111
x-cardenas@rctoyota.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
| 2023 | Year | 12 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058042
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
