UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020934 |
|---|---|
| Receipt number | R000024150 |
| Scientific Title | Safety evaluation of cleansing foam or facial sunscreen for atopic dermatitis patients |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2016/04/19 14:48:04 |
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Basic information
Public title
Safety evaluation of cleansing foam or facial sunscreen for atopic dermatitis patients
Acronym
Safety evaluation of cleansing foam or facial sunscreen for atopic dermatitis
Scientific Title
Safety evaluation of cleansing foam or facial sunscreen for atopic dermatitis patients
Scientific Title:Acronym
Safety evaluation of cleansing foam or facial sunscreen for atopic dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation of the skin with repeated use of cleansing foam or facial sunscreen for atopic dermatitis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of dermatological assessment and questionnaire before and after the repeated use of cleansing foam or facial sunscreen for 1 and 4 weeks
Key secondary outcomes
Blood test, measurement of transepidermal water loss (TEWL) and skin moisture
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Repeated use of a single-agent of cleansing foam or facial sunscreen for 4 weeks
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Japanese females aged from 20 to 50 years old at the time informed consent was provided
2)Patients with mild to moderate atopic dermatitis
3)Patients who provided written informed consent to change from their everyday use of cleanser or facial sunscreen to the test agent during the study period
Key exclusion criteria
･Patients with severe or greater atopic dermatitis
･Patients receiving systemic administration of a drug for a purpose other than atopic dermatitis therapy
･Patients receiving a topically administered drug on the face for a purpose other than atopic dermatitis therapy
･Pregnant women, those who may be pregnant, lactating women, or women who hope to become pregnant during the study period
･Patients for whom the test agent is contraindicated
･Patients who were considered inappropriate for the study by an investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Shiba Palace Clinic
Zip code
Address
Daiwa A Hamamatsucho 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miwa Kaneko |
Organization
SOUKEN Co.,Ltd
Division name
Clinical trial division
Zip code
Address
Daiwa A Hamamatsucho 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Maruho Co., Ltd
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
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
芝パレスクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 08 | 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
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2016 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024150
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
