UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037856 |
|---|---|
| Receipt number | R000043164 |
| Scientific Title | Efficacy study of topical formulations (BH07, BH08) |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/11/11 09:36:29 |
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Basic information
Public title
Efficacy study of topical formulations (BH07, BH08)
Acronym
Efficacy study of topical formulations (BH07, BH08)
Scientific Title
Efficacy study of topical formulations (BH07, BH08)
Scientific Title:Acronym
Efficacy study of topical formulations (BH07, BH08)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the efficacy of BH07 or BH08 on dry skin on the hands.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transition of measured skin properties by instruments
Key secondary outcomes
Questionnaires for QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Washout for 1week -> Applying test formulation (BH07) up to ten a day for 4 weeks -> Post-observation period for 1week
Interventions/Control_2
Washout for 1week -> Applying test formulation (BH08) up to ten a day for 4 weeks -> Post-observation period for 1week
Interventions/Control_3
Washout for 1week -> Applying control formulation up to ten a day for 4 weeks -> Post-observation period for 1week
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
Female
Key inclusion criteria
Subjects with dry skin on the hands
Key exclusion criteria
-Subjects with congenital skin diseases
-Ambulatory patient or subjects who are applying prescription drugs on the hands
-Subjects with any complications which affect the results of this study
-Subjects with menopausal trouble or on menopausal hormone therapy
-Pregnancies, lactations or subjects with suspicion of pregnancy.
-Subjects deemed inappropriate to participate in this study by person in charge of the examination
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Azumi |
| Middle name | |
| Last name | Nagasawa |
Organization
Kao Corporation
Division name
Personal Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-285-68-9443
nagasawa.azumi@kao.com
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Ito |
Organization
Kao Corporation
Division name
Personal Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-285-68-9443
Homepage URL
itou.shoutarou@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9861
morisaki.naoko@kao.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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | 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
48
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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 11 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043164
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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