UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061015 |
|---|---|
| Receipt number | R000069826 |
| Scientific Title | A Study on Protective Agents for Preventing Dry Lips |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/23 11:44:14 |
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Basic information
Public title
A Study on Protective Agents for Preventing Dry Lips
Acronym
A Study for Preventing Dry Lips
Scientific Title
A Study on Protective Agents for Preventing Dry Lips
Scientific Title:Acronym
A Study for Preventing Dry Lips
Region
| Japan |
Condition
Condition
Dry Lips
Classification by specialty
| Dermatology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dry lips often occur as a side effect of cancer chemotherapy and radiation therapy. Currently, petroleum jelly is widely used to prevent dry lips; however, since the petroleum jelly base itself lacks moisturizing properties, it has been suggested that it may not be suitable for fundamentally preventing dryness. Therefore, as a preliminary study to identify a base suitable for preventing dry lips, this study examines the moisture content of the lips in healthy subjects after application of petroleum jelly and compares it with that observed after application of other protective agents.
Translated with DeepL.com (free version)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lip moisture content
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Petrolatum, 3 times a day, for 7 days
Interventions/Control_2
Glycerin, 3 times a day, for 7 days
Interventions/Control_3
Olive oil, 3 times a day, for 7 days
Interventions/Control_4
Lip balm, 3 times a day, for 7 days
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
Key exclusion criteria
People who use lipstick or other lip balms
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Matsuyama University
Division name
College of Pharmaceutical Sciences
Zip code
7908578
Address
4-2 Bunkyo-cho, Matsuyama
TEL
089-925-7111
swatanab@g.matsuyama-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Matsuyama University
Division name
College of Pharmaceutical Sciences
Zip code
7908578
Address
4-2 Bunkyo-cho, Matsuyama
TEL
089-925-7111
Homepage URL
swatanab@g.matsuyama-u.ac.jp
Sponsor or person
Institute
Matsuyama University
Institute
Department
Personal name
Funding Source
Organization
Matsuyama University
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
Ethics committee of Matsuyama University
Address
4-2 Bunkyo-cho, Matsuyama
Tel
089-925-7111
mu-yakugaku@matsuyama-u.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 | 03 | Month | 23 | 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
64
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 | 26 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 03 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069826
