UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060505 |
|---|---|
| Receipt number | R000069220 |
| Scientific Title | Comparative evaluation study of various petrolatum products |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/28 21:48:14 |
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Basic information
Public title
Survey on the differences in the feeling of use of various petrolatum products after application.
Acronym
Petrolatum comparative study
Scientific Title
Comparative evaluation study of various petrolatum products
Scientific Title:Acronym
Petrolatum comparative study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, a questionnaire survey on user experience will be conducted for 12 types of petroleum jelly products that are commonly used as prescription medicines, over-the-counter (OTC) drugs, and cosmetics.
Basic objectives2
Others
Basic objectives -Others
Each formulation will be separately subjected to basic pharmaceutical evaluations of properties such as retardation characteristics and viscosity, and the correlation with the questionnaire results will be assessed as a supplementary analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survey on user experience with each formulation
Key secondary outcomes
For each formulation, the relationship between objective physical properties and subjective evaluations of usability will be assessed, based on pharmaceutical measurements of spreadability, consistency, and bleeding, together with the primary evaluation endpoints.
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Healthy adult volunteers will apply 12 petroleum jelly products that are used as prescription drugs, OTC medicines, and cosmetic products to the skin, and will then complete a questionnaire regarding the usability of each formulation.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Adults aged from their 20s to 80s
2. No history of contact dermatitis caused by pharmaceuticals or related products
3. No wounds or other skin lesions at the application site
4. Individuals who have provided written informed consent to participate in this study
Key exclusion criteria
1. Individuals who are unable or unwilling to provide consent to participate in this study
2. Individuals deemed inappropriate for participation by the study investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Enoki |
Organization
Keio University
Division name
Faculty of Pharmacy
Zip code
105-8512
Address
1-5-30 Shibakoen Minato-ku Tokyo
TEL
03-5400-2656
enoki-yk@keio.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Enoki |
Organization
Keio University
Division name
Faculty of Pharmacy
Zip code
105-8512
Address
1-5-30 Shibakoen Minato-ku Tokyo
TEL
03-5400-2656
Homepage URL
enoki-yk@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Faculty of Pharmacy Research Ethics Committee for Studies Involving Human Subjects
Address
1-5-30 Shibakoen Minato-ku Tokyo
Tel
03-5400-2654
enoki-yk@keio.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
| 2026 | Year | 04 | 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
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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | 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
| 2026 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069220
