UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038781 |
|---|---|
| Receipt number | 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 09:19:20 |
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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
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
ishida.koichi@kao.com
Sponsor or person
Institute
Thomas J. Stephens & Associates, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044214
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