UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047956 |
|---|---|
| Receipt number | R000054674 |
| Scientific Title | A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2024/04/24 15:09:09 |
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Basic information
Public title
A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product
Acronym
A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product
Scientific Title
A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product
Scientific Title:Acronym
A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product
Region
| North America |
Condition
Condition
sensitive skin
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy for long-lasting hydration, itch relief, reduction of redness of a test material.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of itch(VAS method), stratum corneum water content, redness(dermatological assessment) before the application of the test material and after the application of test material for 1 and 2 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 the test material to the lower leg once a day for 2 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 of any ethnicity between 21 to 59 years of age;
b) Subject has a Fitzpatrick Skin Type I-IV Subject has self-perceived sensitive skin;
d) Subject must feel mild to moderate itch on lower legs due to dryness at least once daily and must feel itch at the time of the first visit/screening and the baseline visit;
e) Subject has mild to moderate dryness and redness on lower legs;
f) Subject agrees not to shave/wax/remove hair on the lower legs for the conditioning phase and for the duration of the study once enrolled;
g) Subject agrees not to wash or wet the test sites after test material application at the Baseline visit until completion of the 24 Hour visit;
h) Subject is willing to refrain from the use of washcloths, loofahs, or coarse sponges on lower legs;
i) Subject is willing to refrain from tanning and swimming for the duration of the study;
j) Subject agrees not to start a new exercise program for the duration of the study;
k) Subject agrees to wear clothing that easily allows access to the lower legs at all study visits in order to not rub the lower legs when rolling up the pants;
l) Subject agrees not to wear pantyhose at any study visits;
m) If subject uses OTC itch relievers, they agree to discontinue use on the lower legs but may continue use on other parts of the body;
n) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
o) Subject is dependable and able to follow directions as outlined in the protocol;
p) Subject is willing to participate in all study evaluations;
q) Subject is in generally good health
r) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
s) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
t) Subjects understands and is willing to sign an Informed Consent Form in conformance with 21 CRF Part 50:
Key exclusion criteria
a) Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject experiences repeated scratching that may cause raised areas on the skin which may bleed or become inflected due to the intense nature of the itch;
c) Subject has hives;
d) Subject has dense hair on the lower legs;
e) Subject is a regular user of prescription itch relievers;
f) Subject has used cosmetic itch relievers on the lower legs within one week prior to study start date;
#VALUE!
h) Subject has known allergies to cosmetics or toiletry products;
i) Subject exhibits sunburn, rashes, scratches, burn marks, etc. on the test sites, or has tattoos or piercings which might interfere with study evaluations;
j) Subject exhibits or reports a history of acute or chronic dermatological, medical, and/or physical conditions that would preclude application of the test material and/or could influence the outcome of the study;
k) Subject has participated in a clinical study which involved the legs within one week of study initiation;
l) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
m) Subject has 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 | 14 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 08 | 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=R000054674
