UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052790 |
|---|---|
| Receipt number | R000060232 |
| Scientific Title | A Comparative Study of Transepidermal Water Loss and Stratum Corneum Hydration before and after Application of Petroleum Jelly and Commercial Moisturizers |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2025/05/15 09:19:57 |
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Basic information
Public title
Comparison of Moisturizing Effects of Emollients and Commercial Moisturizers
Acronym
Protective Agent Evaluation (PAE) Trial
Scientific Title
A Comparative Study of Transepidermal Water Loss and Stratum Corneum Hydration before and after Application of Petroleum Jelly and Commercial Moisturizers
Scientific Title:Acronym
Petroleum jelly and commercial moisturizers Application's effect on transepidermal water loss and stratum corneum hydration (PAE trial)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Atopic dermatitis is characterized by compromised skin barrier function. The use of moisturizers effectively improves skin hydration and alleviates symptoms. While Vaseline and various moisturizers are recommended in clinical guidelines, there is a lack of in-depth research on the efficacy of over-the-counter moisturizers. The purpose of this study is to measure transepidermal water loss (TEWL) and stratum corneum hydration before and after the use of white petroleum jelly and over-the-counter moisturizers in adults over the age of 20. The variance in these measurements will be used to evaluate the moisturizing effects of the products. The results are expected to improve the appropriate use of medicated moisturizers and aid in self-care practices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of transepidermal water loss and stratum corneum hydration before and 2 hours after application of petroleum jelly to the left inner forearm and a commercial moisturizer to the right inner forearm.
Key secondary outcomes
(1) Comparison of the levels of transepidermal water loss and stratum corneum hydration before and at 1, 3, and 4 hours after application of petroleum jelly to the inner left upper arm versus a commercial moisturizer to the inner right upper arm.
(2) Comparison of transepidermal water loss and stratum corneum hydration before and at 1, 3, and 4 hours after application of three different commercial moisturizers to the inner right upper arm.
(3) Comparison of comfort levels associated with the application of different moisturizers using a Likert scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention Group: (1) PIGEON Baby Milk Lotion Moisture Plus (Pigeon Corporation)
Control Group: White petroleum jelly: Baby Vaseline (Kenei Pharmaceutical Co., Ltd.)
Interventions/Control_2
Intervention Group: (2) Johnson Baby Lotion, Fragrance Free (Johnson & Johnson)
Control Group: White petroleum jelly: Baby Vaseline (Kenei Pharmaceutical Co., Ltd.)
Interventions/Control_3
Intervention Group: (3) Nivea Skin Milk Moist (Nivea Kao Corporation)
Control Group: White petroleum jelly: Baby Vaseline (Kenei Pharmaceutical Co., Ltd.)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals who are 20 years of age or older.
2. Individuals who have given informed consent to participate in this research by signing a consent form.
Key exclusion criteria
Individuals with obvious wounds at the intended application site.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Nakajima |
Organization
Allergy Clinic Penguin for children & families
Division name
Allergy Clinic Penguin for children & families
Zip code
431-1112
Address
3393-6 ohitomi, Nishi-ku, Hamamatsu city, Shizuoka
TEL
053-482-2020
ray@penguin-allergy.jp
Public contact
Name of contact person
| 1st name | Shuka |
| Middle name | |
| Last name | Aono |
Organization
Kyorindo Co., Ltd.
Division name
P-one plaza tenno store
Zip code
435-0052
Address
1982-3 Tenno-cho, Higashi-ku, Hamamatsu City, Shizuoka
TEL
053-465-7431
Homepage URL
aonoshuka@gmail.com
Sponsor or person
Institute
Allergy Clinic Penguin for children & families
Institute
Department
Personal name
Funding Source
Organization
Kyorindo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jikei University Katsushika Medical Center, Department of Pediatrics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine Ethics Committee
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
Tel
053-435-2680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23-221
Org. issuing International ID_1
Hamamatsu University School of Medicine Ethics Committee
Study ID_2
35-289:11920
Org. issuing International ID_2
Jikei University School of Medicine ethics committee
IND to MHLW
Institutions
Institutions
子ども＆ファミリーアレルギークリニックペンギン（静岡県）、株式会社杏林堂薬局（静岡県）、東京慈会医科大学葛飾医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 13 | 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
48
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to delay in submitting the paper.
Date of the first journal publication of results
Baseline Characteristics
Of those attending the November 3, 2023 and December 3, 2023 skin care training sessions
Those who meet all of the following criteria are eligible
1. 20 years of age or older
2. Persons who have given their consent to participate in this study by signing a consent form.
5.3 Exclusion criteria
Persons who meet any of the following criteria
1. Subjects who have obvious trauma to the site of application.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 13 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 13 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060232
