UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019447 |
|---|---|
| Receipt number | R000022494 |
| Scientific Title | A study to see the dermatological efficacy of XXXXI on healthy skin |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2015/12/21 18:24:32 |
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Basic information
Public title
A study to see the dermatological efficacy of XXXXI on healthy skin
Acronym
A study to see the dermatological efficacy of XXXXI on healthy skin
Scientific Title
A study to see the dermatological efficacy of XXXXI on healthy skin
Scientific Title:Acronym
A study to see the dermatological efficacy of XXXXI on healthy skin
Region
| North America |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of XXXXI on the sebum secretion of healthy females.
XXXXI is the code name of the material.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
valuation of the sebum content, the sebum composition, the gene expressions, the skin flora, the skin color and the dermatological assessment before the application of XXXXI and after the application of XXXXI for 4 and 6 weeks
Key secondary outcomes
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 Sample to the face skin twice daily for 6 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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1_Panelists who are females, ages 18-45, Caucasians and African Americans.
2_Panelists who possess a sufficient amount of sebum.
3_Panelists who are willing to avoid sun exposure, tanning beds, sunless tanners, and skin lightening products until the study completes.
4_Panelists who agree to follow their typical daily routine and refrain from starting any new activities (e.g. swimming, tanning bed usage, exercising, sunbathing, etc.).
5_Panelists who are willing to use only the provided test products in place of their own personal facial cleansers, facial moisturizers, and facial pore strips for the duration of the study.
6_Panelists are allowed to continue using their own personal cosmetic/make-up items (foundation, eye-shadow, mascara, etc.).
7_Panelists who agree to refrain from the use of any their own personal cosmetic/make-up items, especially for sebum regulation, anti-bacterial, and anti-inflammation.
8_Panelists who agree to refrain from the use of any supplements, OTC or prescription medications, especially for sebum regulation, anti-bacterial, and anti-inflammation.
9_Panelists who are willing to wash their faces at the night before each lab visit and refrain from applying any facial moisturizers, facial products, or make-up on their faces prior to the lab visits.
10_Panelists who are willing to have photographs and measurements taken on their faces.
Key exclusion criteria
1_Panelists who have a known allergy or sensitivity to any facial care product, facial moisturizer, facial cleanser, pore strip, or to any specific ingredient or fragrance used in these types of products.
2_Panelists having illnesses or diseases which in the opinion of the investigator, might interfere with the conduct of the study or the interpretation of results.
Especially panelists with any skin irritation, skin condition (such as rosacea, eczema, atopic dermatitis, or psoriasis), or severe acne on their face.
3_Panelists who take OTC or prescription medications which, in the opinion of the investigator, might interfere with the conduct of the study or the interpretation of results.
4_Panelists who have used a topical antibiotic on their faces in the last two weeks.
5_Panelists under the care of a doctor or dermatologist taking prescription medication (topical or oral) for any facial skin issues.
6_Panelists who have started any type of estrogen or hormone therapy including birth control pills in the last four weeks and/or are planning to start them during the study.
Panelists who are pregnant, planning to be pregnant, or breastfeeding
7_Panelists who have used pore strips on their faces in the
last two weeks.
8_Panelists who have undergone chemical peeling on their faces in the last six months.
9_Panelists who have undergone laser therapy, or phototherapy on their faces in the last six months.
10_Panelists currently participating in, or scheduled to participate in, another facial study during the study period.
11_Panelists who work for, or have household members who work for, a manufacturer or advertiser of personal care products.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Takahashi |
Organization
Kao Corporation
Division name
R&D -Core Technology-Biological Science Research
Zip code
Address
5-3-28, Kotobuki-tyou, Odawara-shi, Kanagawa, 250-0002, JAPAN
TEL
0465-34-6116
takahashi.yoshito@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arisa Katou |
Organization
Kao Corporation
Division name
R&D -Core Technology-Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7498
Homepage URL
katou.arisa@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Spring Grove Laboratories(KY, USA)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 21 | 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
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 20 | 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
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022494
