UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048155 |
|---|---|
| Receipt number | R000054881 |
| Scientific Title | Effects on the skin due to the different number of cosmetic items used : single blinded study |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2023/12/25 11:34:29 |
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Basic information
Public title
Effects on the skin due to the different number of cosmetic items used
Acronym
LMPC study
Scientific Title
Effects on the skin due to the different number of cosmetic items used : single blinded study
Scientific Title:Acronym
Effects on the skin due to the different number of cosmetic items used
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the difference in skin effects in three groups with different numbers of cosmetic items used
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement by equipment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use three test articles on only one side of the face
Interventions/Control_2
Use two test articles on only one side of the face
Interventions/Control_3
The other side of the face, no using test article
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
| 35 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Subjects whose wrinkle class in the outer corner is 1 to 3
2. Subjects whose skin is dry
3. Subjects with spots or pigmentation on the face
Key exclusion criteria
1. Subjects with cosmetic allergies
2. Subjects who are pregnant or lactating
3. Subjects with inflamed or scraped skin on face
4. Subjects who are taking medicine for pigmentation, those who are treating pigmentation
5. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Masatomo |
| Middle name | |
| Last name | Najima |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Faith Co., Ltd.
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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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 | 27 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
29
Results
<3 product groups: comparison with unused side>
Improvement after 8 weeks: face line angle, gill angle, stratum corneum moisture content, elasticity R2, crow's feet wrinkles
<2 product groups: comparison with unused side>
Improvement after 8 weeks: face line angle, gill angle, stratum corneum moisture content, pore number, pore score, elasticity R2, R5, R7, crow's feet wrinkles
Exacerbation after 8 weeks: Number of grains/texture score
Results date posted
| 2023 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty participants started the study, one withdrew due to personal reasons, and 29 completed the study (female, 35-49 years old, mean age 43.5 years).
Group A (3-product use group): 35 to 48 years old, average age 43.5 years.
Group B (2-product group): 37 to 49 years old, average age 43.5 years old
Participant flow
Group A (3-product group): 15 people participated, all completed the study, and 15 people were analyzed.
Group B (2-product group): 15 participants, 1 discontinued, 14 subjects were analyzed.
Adverse events
no
Outcome measures
Measurement by equipment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | 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 | 24 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054881
