UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037554
Receipt No. 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 (Ver. 2)

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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
Email 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
Email ishida.koichi@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042816