UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056583 |
|---|---|
| Receipt number | R000064663 |
| Scientific Title | he Effect of Skin Care Lotions on Atopic Dermatitis.: Placebo-controlled, double-blind, randomized, parallel-group comparison study |
| Date of disclosure of the study information | 2025/01/07 |
| Last modified on | 2024/12/26 18:54:15 |
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Basic information
Public title
The Effect of Skin Care Lotions on Atopic Dermatitis.
Acronym
The Effect of Skin Care Lotions on Atopic Dermatitis.
Scientific Title
he Effect of Skin Care Lotions on Atopic Dermatitis.:
Placebo-controlled, double-blind, randomized, parallel-group comparison study
Scientific Title:Acronym
he Effect of Skin Care Lotions on Atopic Dermatitis.:
Placebo-controlled, double-blind, randomized, parallel-group comparison study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Apply skin care lotions for 4 consecutive weeks and evaluate the actual improvement in atopic dermatitis symptoms (satisfaction).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physician's findings
Post-use satisfaction questionnaire
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply test products for 4 weeks
Interventions/Control_2
Apply placebo products for 4 weeks
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects of men and women aged 20 to 59
(2) Subject with mild or higher atopic dermatitis symptoms
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1)Subjects using oral medications (steroids, antiallergic drugs) and topical steroids for atopic dermatitis
(2)Subjects with a history of diabetes mellitus, liver disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, disease affecting the secretion of adrenal corticosteroids, or other serious diseases.
(3)Subjects who have undergone gastrointestinal surgery
(4)Subjects with diseases currently being treated.
(5)Subjects who are allergic to food and drugs
(6)Subjects with significant abnormalities in skin manifestations at the test site or with symptoms of severe atopic dermatitis.
(7)Subjects whose skin condition changes drastically due to irregular menstruation or menstruation.
(8)Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects.
(9)Subjects who play intense sports and subjects who are on a diet.
(10)Subjects with extremely irregular eating habits
(11)Subjects who may be exposed to excessive ultraviolet light during the study period.
(12)Subjects who visit beauty salons for skin care
(13)Subjects who ingest health foods (including foods for specified health uses and foods with functional claims) and designated quasi-drugs that affect the skin or atopic dermatitis during the study period
(14)Subjects who are continuously treated with medications (including OTC, prescription drugs)
(15)Subjects who drink more than 40 g of pure alcohol per day, who consume excessive alcohol, or who are unable to abstain from alcohol on the day before the testSubjects who are unable to perform the testing procedures to be conducted during the study period as specified (e.g., questionnaire responses)
(16) and beyond are described in Other related information.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Pias Corporation
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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府） Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 07 | 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
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(16)Subjects who smoke an average of 21 or more cigarettes per day
(17)Subjects who are participating in or will participate in other clinical trials at the start of this study
(18)Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Management information
Registered date
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064663
