UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047958 |
|---|---|
| Receipt number | R000054677 |
| Scientific Title | In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2024/04/24 15:10:12 |
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Basic information
Public title
In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material
Acronym
In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material
Scientific Title
In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material
Scientific Title:Acronym
In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material
Region
| North America |
Condition
Condition
sensitive skin
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dermal irritation potential of a test material.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dermal evaluation by a dermatologist before and 4 weeks after use of a test material.
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
Wash the body once a day with the test mterial for 4 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
| 21 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Subject is male or female between 21 to 59 years of age (age and sex to be captured in the demographics);
b) A subject exhibits no edema at the Baseline visit;
c) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
d) Subject agrees not to use their regular body cleanser during the duration of the study;
e) Subject is a regular user of any type of body cleanser (brand to be captured in the demographics);
f) Subject identifies as having self-perceived eczema prone skin;
g) Subject has at least one of three conditions: significantly dry skin (2: mild to 3: moderate dry skin as determined by a board certified dermatologist),
history of eczema, or history of atopic diathesis (skin condition to be captured in the demographics);
h) Subject agrees to refrain from tanning and swimming for the duration of the study;
i) Subject agrees not to start a new exercise program for the duration of the study;
j) Subject is dependable and able to follow directions as outlined in the protocol and usage instructions provided by the Sponsor;
k) Subject is willing to participate in all study evaluations;
l) Subject is in generally good health and has a current Panelist Profile Form on file at ECRL;
m) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
n) Subjects understands and is willing to sign an Informed Consent Form in conformance with 21 CRF Part 50: "Protection of Human Subjects."
Key exclusion criteria
a) Female subject (if applicable) is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study;
c) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study;
d) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
e) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
f) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
g) Subject has insulin-dependent diabetes.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | AKINORI |
| Middle name | |
| Last name | INOUE |
Organization
Lion Corporation
Division name
Global Development Center
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan,132-0035
TEL
08012731828
ino-aki@lion.co.jp
Public contact
Name of contact person
| 1st name | AKINORI |
| Middle name | |
| Last name | INOUE |
Organization
Lion Corporation
Division name
Global Development Center
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan,132-0035
TEL
08012731828
Homepage URL
ino-aki@lion.co.jp
Sponsor or person
Institute
Lion Corporation
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Advarra IRB
Address
6100 Merriweather Drive, Suite 600 Columbia, Maryland 21044
Tel
4108842900
ino-aki@lion.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 07 | 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
35
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
| 2022 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054677
