UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029305
Receipt No. 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 2017/10/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email fukagawa.satoko@kao.co.jp

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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 27 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
2017 Year 09 Month 27 Day
Last modified on
2017 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033343

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.