UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049354 |
|---|---|
| Receipt number | R000056205 |
| Scientific Title | Evaluation of anti-wrinkle effect of BB cream N-02, An intra-individual comparison between half of the face treated and half untreated |
| Date of disclosure of the study information | 2022/10/28 |
| Last modified on | 2023/05/01 09:49:53 |
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Basic information
Public title
Evaluation of anti-wrinkle effect of BB cream N-02
Acronym
Evaluation of anti-wrinkle effect of BB cream N-02
Scientific Title
Evaluation of anti-wrinkle effect of BB cream N-02, An intra-individual comparison between half of the face treated and half untreated
Scientific Title:Acronym
Evaluation of anti-wrinkle effect of BB cream N-02, An intra-individual comparison between half of the face treated and half untreated
Region
| Japan |
Condition
Condition
healthy adult female
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of the test product in reducing the appearance of fine lines and wrinkles caused by dryness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness
1.Photographic wrinkle grade evaluation
2.Calculation of wrinkle analysis parameters for each replica with 3D analysis equipment
Key secondary outcomes
safety
1.Self-report of subjective symptoms
2.Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the test product cream to the right half of the face once a day for 4 consecutive weeks
Interventions/Control_2
Apply the test product cream to the left half of the face once a day for 4 consecutive weeks
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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Subjects with a wrinkle grade of 1 to 3 at the time of screening
2.Healthy Japanese women aged 35 to 59 years at the time of screening
3.Subjects who have been fully informed of the purpose of this study and the test product, and who have given their written consent to participate in the study of their own free will.
Key exclusion criteria
1.Subjects who have a clear difference in wrinkle grades between left and right half of the face at the time of screening
2.Subjects who have factors that will affect the evaluation of this study on the test site (disease such as atopic dermatitis, trauma, burns, inflammation, acne, warts, or traces thereof)
3.Subjects who have a history of medical cosmetic treatment that will affect the evaluation of this study at the test site, or those who plan to receive it during the study period
4.Subjects who have received special treatment (facial treatment, etc.) on the test site within the past 3 months, or those who plan to receive it during the study period
5.Pregnant or breastfeeding
6.Subjects who have experienced severe skin symptoms many times due to the use of cosmetics in the past
7.Subjects who use skin care products that advocate or claim indications related to this test product on the test site
8.Subjects using a product (BB cream) for the same application as the test product on the test site
9.Subjects who use lotion, all-in-one products, or a combination of lotion and all-in-one products only for daily skin care.
10.Subjects who are judged to be ineligible by the principal investigator, etc. with other reasons.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido
TEL
011-882-0111
Homepage URL
matsuda@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Noevir 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
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido
Tel
011-881-0111
matsuda@ughp-cpc.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 | 10 | Month | 28 | 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
18
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 | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 02 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056205
