UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019217 |
|---|---|
| Receipt number | R000022063 |
| Scientific Title | The evaluation for effectiveness of ceramide cream for skin diseases with barrier dysfunction |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/02/12 15:46:43 |
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Basic information
Public title
The evaluation for effectiveness of ceramide cream for skin diseases with barrier dysfunction
Acronym
The evaluation for effectiveness of ceramide cream for skin diseases with barrier dysfunction
Scientific Title
The evaluation for effectiveness of ceramide cream for skin diseases with barrier dysfunction
Scientific Title:Acronym
The evaluation for effectiveness of ceramide cream for skin diseases with barrier dysfunction
Region
| Japan |
Condition
Condition
Skin diseases with barrier dysfunction
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of ceramide cream for skin diseases with barrier dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effectiveness of ceramide cream for skin diseases with barrier dysfunction is assessed with skin color and induration in erythema every week.
Key secondary outcomes
Safety of ceramide cream for skin diseases with barrier dysfunction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical application of ceramide cream twice a day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with psoriasis
Key exclusion criteria
Patients with the other inflammatory skin diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Department of Dermatology
Zip code
Address
185-1 Kohasu, Okohcho, Nankoku, Kochi
TEL
088-866-5811
nakajimk@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Department of Dermatology
Zip code
Address
185-1 Kohasu, Okohcho, Nankoku, Kochi
TEL
088-866-5811
Homepage URL
nakajimk@kochi-u.ac.jp
Sponsor or person
Institute
Department of Dermatology,Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology,Kochi Medical School, Kochi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
高知大学医学部附属病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 01 | 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
Results
The ceramide cream was not effective for skin lesions with barrier dysfunction in 5 patients.
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022063
