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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036823
Receipt No. 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

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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
Email 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
Email yohei-kawano@rs.tus.ac.jp

Sponsor
Institute Tokyo University of Science
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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