UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046661 |
|---|---|
| Receipt number | R000053227 |
| Scientific Title | Safety evaluation of novel shampoo in patients with Dry skin disease including sebum deficiency eczema and atopic dermatitis |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2022/03/30 09:21:39 |
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Basic information
Public title
Safety evaluation of novel shampoo
Acronym
Safety evaluation of novel shampoo
Scientific Title
Safety evaluation of novel shampoo in patients with Dry skin disease including sebum deficiency eczema and atopic dermatitis
Scientific Title:Acronym
Safety evaluation of novel shampoo in patients with Dry skin disease including sebum deficiency eczema and atopic dermatitis
Region
| Japan |
Condition
Condition
Persons with mild to moderate dry skin disease(including sebum deficiency eczema and atopic dermatitis)
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and usefulness of the test bath solution after use for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin findings(1)and adverse events(2):dermatologist examination,questionnaire for skin condition and the impression of test bath solution,recording daily life
(1)0 week,2 week,4 week
(2)2 week,4 week
Key secondary outcomes
Improvement of dryness and desquamation(dermatologist examination,photographic recording)
0 week,2 week,4 week
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
Use of the test shampoo at least 4 days a week 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with mild to moderate dry skin disease(including Sebum deficiency eczema and atopic dermatitis)
2.Patients with minor to moderate dry skin symptoms at the examination areas
3.Japanese men and women between the ages of 20 and 69
4.Patients giving written informed consent with his or her own will after receiving an adequate information about the test bath solution and aim of this study
Key exclusion criteria
1.Patients with rashes at the examination areas that intervene the evaluation
2.Patients with rosacea-like dermatitis or with steroid skin disease
3.Patients who take or anticipate to take medicines that affect the study such as oral steroids, immunosuppresant
4.Those who used cosmetics or quasi-drugs for the same purpose (hair wash) as the test product on the test site
5.Pregnant women
6.Lactating women
7.Patients who have experienced severe skin symptoms many times due to the use of cosmetics in the past
8.Patients who are judged as inappropriate by principal investigator or sub-investigator with other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Center for Clinical Pharmacology
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Center for Clinical Pharmacology
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
TEL
011-882-0111
Homepage URL
matsuda@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Shiseido Japan 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
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-881-0111
matsuda@ughp-cpc.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 17 | 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
| 2022 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053227
