UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037554 |
|---|---|
| Receipt number | R000042816 |
| Scientific Title | An evaluation of pseudoceramides in mild to moderate atopic dermatitis. |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2019/07/31 15:15:12 |
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Basic information
Public title
Efficacy test of moisturizer in atopic dermatitis.
Acronym
Efficacy test of moisturizer in atopic dermatitis.
Scientific Title
An evaluation of pseudoceramides in mild to moderate atopic dermatitis.
Scientific Title:Acronym
Efficacy test of moisturizer in atopic dermatitis.
Region
| North America |
Condition
Condition
Atopic dermatitis (mild to moderate)
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the efficacy and tolerability of a pseudoceramide moisturizer in subjects with mild to moderate atopic dermatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the study moisturizer on the efficacy by the change of atopic dermatitis severity, and tolerability and safety during the study.
Key secondary outcomes
Evaluation of the study moisturizer on the change of skin surface hydration, barrier function, skin surface topography and determination of ceramides of the stratum corneum.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After a washout of all topical medications and moisturizer for 1 week, apply the study moisturizer morning and evening for 4 weeks.
After completion of the 4-week treatment phase, discontinue the use of test moisturizer for a 1-week regression period.
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Subjects 18+ years old.
-Subjects with mild to moderate atopic dermatitis.
Key exclusion criteria
-Subjects who have any dermatological disorder, which in the investigator's opinion, could interfere with the accurate evaluation of the subject's skin characteristics.
-Subjects on any other atopic dermatitis therapy.
-Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study moisturizer.
-Subjects who are pregnant, breast feeding or planning a pregnancy.
-Subjects with clinically significant unstable medical disorders.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Zoe |
| Middle name | Diana |
| Last name | Draelos |
Organization
Dermatology Consulting Services
Division name
Dermatology Consulting Services
Zip code
27262
Address
2444 North Main Street, High Point, North Carolina 27262, USA
TEL
+1-336-841-2040
zdraelos@northstate.net
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Ishida |
Organization
Kao Corporation
Division name
R&D Strategy
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-9404
Homepage URL
ishida.koichi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Concordia Clinical Research IRB
Address
7 East Frederick Place, Cedar Knolls, New Jersey 07927
Tel
+1-973-734-0734
zdraelos@northstate.net
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
Dermatology Consulting Services (North Carolina, USA)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
40
Results
in submission
Results date posted
| 2019 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
in submission
Participant flow
in submission
Adverse events
in submission
Outcome measures
in submission
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 04 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042816
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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