UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041829 |
|---|---|
| Receipt number | R000047752 |
| Scientific Title | Placebo-controlled, double-blind, randomized controlled trials that verify moisturizing effect of patients with atopic dermatitis by lotion containing plant extract. |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2022/09/20 17:36:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification test of Moisturizing effect for patients with atopic dermatitis.
Acronym
Verification test of Moisturizing effect.
Scientific Title
Placebo-controlled, double-blind, randomized controlled trials that verify moisturizing effect of patients with atopic dermatitis by lotion containing plant extract.
Scientific Title:Acronym
Placebo-controlled, double-blind, randomized controlled trials that verify moisturizing effect.
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of continuous application for 12-weeks of the moisturizing lotion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum water content
Key secondary outcomes
Skin observation by doctor
Transepidermal water loss
Microscope photography
Collecting stratum corneum
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Continuous application for 12-weeks two types of the moisturizing lotion (Placebo on the left, Lotion containing plant extract on the right).
Interventions/Control_2
Continuous application for 12-weeks two types of the moisturizing lotion (Placebo on the right, Lotion containing plant extract on the left).
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Individuals with mild atopic dermatitis.
2)Individuals with dryness on the inside of the left and right forearms.
3)Individuals who agree to participate in this test after understanding the explanation of exam and show willingness to participate in the exam.
Key exclusion criteria
1)Individuals with moderate or higher atopic dermatitis.
2)Individuals who are taking orally steroids, antihistamine, anti-allergic agent, immunosuppressant, tranquilizers.
3)Individuals who have serious allergy by the use of topical drugs, cosmetics, quasi drugs and others in the past.
4)Individuals considered to be inappropriate for inclusion to have a serious illness.
5)Individuals who are being treated or hospitalized due to illness (Excluding colds and dentistry).
6)Individuals who have a family that are working at Pharmaceutical company or cosmetic company.
7)Individuals who are currently participating on survey using foods, cosmetics and quasi drugs, or are participating on any other clinical study, or have done so in the previous four weeks.
8)Individuals who are regarded to be inappropriate for this study by doctors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Numano |
Organization
Numano Clinic
Division name
Dermatologist
Zip code
370-0815
Address
15, Yanagawachou, Takasaki-shi, Gunma, Japan
TEL
027-322-2926
kaco121@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Inai |
Organization
FUJI-SANGYO CO.,LTD
Division name
Research and Development Laboratory
Zip code
763-0071
Address
1301, Tamurachou, Marugame-shi, Kagawa, Japan
TEL
0877-25-3221
Homepage URL
inai@fuji-sangyo.co.jp
Sponsor or person
Institute
FUJI-SANGYO CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
FUJI-SANGYO CO.,LTD
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
General Incorporated Association Crinical Research Review Center
Address
2972-8-603 Ishikawamachi Hachioji-shi,Tokyo,192-0032,JAPAN
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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
| 2020 | Year | 09 | Month | 18 | 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
25
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
| 2020 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047752
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
