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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037856
Receipt No. 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

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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
Email 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
Email itou.shoutarou@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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