UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036823 |
|---|---|
| Receipt number | R000041944 |
| Scientific Title | Research on the correlation between rheological evaluation and sensory evaluation of carbopol gel |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/05/22 17:46:22 |
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Basic information
Public title
Study on Coating Feel of Carbopol Gel
Acronym
Study on Coating Feel of Carbopol Gel
Scientific Title
Research on the correlation between rheological evaluation and sensory evaluation of carbopol gel
Scientific Title:Acronym
Research on the correlation between rheological evaluation and sensory evaluation of carbopol gel
Region
| Japan |
Condition
Condition
Acne vulgaris
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The measurement of physical property values (frictional stress, elastic modulus, etc.) of CP gel using a creep meter and the coating comfort questionnaire survey of CP gel in healthy persons are conducted to evaluate the correlation between the two. Based on this result, we aim to establish prescription design guidelines for CP gel preparations by determining the measurement method and its value that are most suitable for evaluation of the coating feeling of CP gel.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Five points of [Easy to extract from tube], [Easy to spread], [Easy to fit], [Smoothness], [Betting] and [Trip feeling] are evaluated in seven stages by the SD method (meaning discrimination law).
Key secondary outcomes
For each sample, comprehensive evaluation (good or bad) is evaluated in seven stages by the SD method.
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
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Educate subjects on sensory evaluation methods.
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Twenties women
2. Tokyo University of Science faculty and students who obtained their consent to cooperate with this research
Key exclusion criteria
1. Minor
2. Person who has skin disease
3. Those who have shown allergies or hypersensitivity to external skin preparations in the past
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Aoyama |
Organization
Tokyo University of Science
Division name
Faculty of Pharmacy
Zip code
278-8510
Address
2641 Yamazaki, Noda-shi Chiba, Japan
TEL
04-7124-1501
t-aoyama@rs.noda.tus.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kawano |
Organization
Tokyo University of Science
Division name
Faculty of Pharmacy
Zip code
278-8510
Address
2641 Yamazaki, Noda-shi Chiba, Japan
TEL
04-7124-1501
Homepage URL
yohei-kawano@rs.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Science
Address
2641 Yamazaki, Noda-shi Chiba, Japan
Tel
04-7124-1501
yohei-kawano@rs.tus.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
| 2019 | Year | 06 | Month | 01 | 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
10
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
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2019 | 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
| 2019 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041944
