UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029305 |
|---|---|
| Receipt number | R000033343 |
| Scientific Title | A study for the short-term application of topical product CG_01. |
| Date of disclosure of the study information | 2017/09/27 |
| Last modified on | 2019/10/01 10:08:59 |
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Basic information
Public title
A study for the short-term application of topical product CG_01.
Acronym
A study for the short-term application of topical product CG_01.
Scientific Title
A study for the short-term application of topical product CG_01.
Scientific Title:Acronym
A study for the short-term application of topical product CG_01.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the topical agent on components of the skin and its relevance to skin conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The dryness score of the skin before and after application.
Key secondary outcomes
The skin hydration, pH, the image analysis of the skin surface, the analysis of components of the skin, the analysis of the questionnaire before and after application.
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
| Other |
Interventions/Control_1
Apply the active agent to the one side of the cheek and the placebo to other side of the cheek twice a day for 8 days.
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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy males aged from 25 to 50 years old.
2. Subjects with a high dryness score and a low skin hydration of the cheek selected by screening test.
3. Subjects who can agree to participate in the study and provide written informed consent.
Key exclusion criteria
1. Subjects with atopic dermatitis, contact dermatitis and cutaneous hypersensitivity
2. Subjects with problems in the skin of the face, such as wound, eczema, sunburn.
3. Subjects who is using topical agent on the skin of the face.
4. Subjects who attend a hospital or who take drugs.
5. Subjects with any allergies.
6. Subjects who is undergoing, or have received, medical cosmetic treatment such as chemical peeling, cosmetic surgery.
7. Smoker.
8. Subjects who is participating in, or have participated in, other clinical study.
9. Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinobu Mori |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7460
mori.shinobu@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Fukagawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7579
Homepage URL
fukagawa.satoko@kao.co.jp
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
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 27 | 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
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033343
| 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 |
