UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047970 |
|---|---|
| Receipt number | R000054685 |
| Scientific Title | Pediatric Safety In-Use and Consumer Perception Evaluation |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2024/04/24 15:07:01 |
* 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
Pediatric Safety In-Use and Consumer Perception Evaluation
Acronym
Pediatric Safety In-Use and Consumer Perception Evaluation
Scientific Title
Pediatric Safety In-Use and Consumer Perception Evaluation
Scientific Title:Acronym
Pediatric Safety In-Use and Consumer Perception Evaluation
Region
| North America |
Condition
Condition
Healthy subjects
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
Apply the test material to the body once a day 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
| 6 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Subject exhibits no edema, no greater than barely perceptible erythema, and no greater than slight (1) dryness of the test sites at baseline;
b) Subject's parent/legal guardian agrees to refrain from applying any other products to the test sites, other than the provided test material, for the duration of the study;
c) Subject's parent/legal guardian agrees not to introduce any new cosmetic or toiletry products during the study;
d) Subject's parent/legal guardian is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
e) Subject's parent/legal guardian allows the subject to participate in all study evaluations;
f) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
g) Subject's parent/legal guardian has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
h) Subject's parent/legal guardian understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects."
Key exclusion criteria
a) 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;
b) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study;
c) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
d) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
e) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
f) 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 | 07 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 21 | 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=R000054685
