UMIN-CTR Clinical Trial

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
Last 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
1st 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