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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038781
Receipt No. R000044214
Scientific Title An evaluation of a lotion base with and without ceramide complex on atopic dermatitis.
Date of disclosure of the study information 2019/12/04
Last modified on 2019/12/04

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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 a lotion base with and without ceramide complex on atopic dermatitis.
Scientific Title:Acronym Efficacy test of moisturizer in atopic dermatitis.
Region
North America

Condition
Condition Atopic dermatitis (mild to severe)
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the efficacy and tolerability of a moisturizer containing Ceramide Complex versus baseline and versus a vehicle moisturizer when used by indivisuals with mild to severe atopic dermatitis
To assess how Ceramide Complex may impact a change in ceramide balance in the stratum corneum.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in clinical grading scores hydration (Corneometer), and barrier (Tewameter) when comparing test product to baseline at post-baseline time points.
The presence of pseudoceramide in the stratum corneum of test product treated skin.
Key secondary outcomes Changes in clinical grading scores, hydration (Corneometer), and barrier (Tewameter) when comparing test product to the vehicle moisturizer at post-baseline time points.
No significant worsening in objective or subjective symptoms of skin irritation at post-baseline time points.
A significantly greater proportion of positive responses versus negative responses of self-assessment questionnaires.

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 After a washout of any topical moisturizing products, any topical prescription treatments and any OTC treatments, apply the test product in the split-body twice per day for the 4-week treatment period.
After completion of the 4-week treatment period, discontinue test material usage as regression phase of 6 days.
Interventions/Control_2 After a washout of any topical moisturizing products, any topical prescription treatments and any OTC treatments, apply the vehicle in the split-body twice per day for the 4-week treatment period.
After completion of the 4-week treatment period, discontinue test material usage as regression phase of 6 days.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -15 years of age and older, females and males.
-Individuals with clinically determined mild to severe atopic dermatitis by Hanifin & Rajka.
-Individuals with a minimum of 1 active atopic dermatitis lesion, of mild to severe severity based on the ADSI.
-The order of preference for the lesional sites are as follows:
-Contra-lateral forearm lesions
-Single forearm lesion
-Contra-lateral lesions from other area
-Single lesions from other areas
Key exclusion criteria -Individuals with known allergies to any topical moisturizing product.
-Individuals with any dermatological condition that would interfere with study assessments or increase the risk to the subjects.
-Individuals who have any medical conditions which makes the candidate an inappropriate subject for study participation.
-Individuals with uncontrolled medical conditions such as hypertension, thyroid disease, diabetes, etc.
-Females who are pregnant or nursing or planning to become pregnant during the course of the study.
-Individuals who are currently participating on any other clinical study, or have done so in the previous two weeks.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Ronald
Middle name
Last name Rizer
Organization Thomas J. Stephens & Associates, Inc.
Division name Colorad Research Center
Zip code 80915
Address 5050 Edison Avenue, Suite 202 Colorado Springs, CO 80915 USA
TEL +1-719-637-2828
Email rrizer@stephens-associates.com

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 Thomas J. Stephens & Associates, Inc.
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IntegReview IRB
Address 3001 S. Lamar Blvd., Suite 210 Austin, Austin, TX 78704
Tel +1-512-326-3001
Email integreview@integreview.com

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 Thomas J. Stephens & Associates, Inc. Colorado Research Center
(Colorado, USA)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 04 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications Preparing for submission
Number of participants that the trial has enrolled 45
Results
Preparing for submission
Results date posted
2019 Year 12 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Preparing for submission
Participant flow
Preparing for submission
Adverse events
Preparing for submission
Outcome measures
Preparing for submission
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 02 Month 01 Day
Date of IRB
2011 Year 02 Month 01 Day
Anticipated trial start date
2011 Year 02 Month 02 Day
Last follow-up date
2011 Year 03 Month 27 Day
Date of closure to data entry
2011 Year 04 Month 15 Day
Date trial data considered complete
2011 Year 04 Month 30 Day
Date analysis concluded
2011 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 12 Month 04 Day
Last modified on
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044214

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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