UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058202 |
|---|---|
| Receipt number | R000066540 |
| Scientific Title | Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/17 12:03:34 |
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Basic information
Public title
Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery
Acronym
Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery
Scientific Title
Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery
Scientific Title:Acronym
Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the effect of a new skincare formulation (FQWO71W1) on rough skin recovery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation of skin condition after repeated use of a new skincare formulation (FQWO71W1)
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
The new skincare formulation (FQWO71W1) and placebo will be applied repeatedly to areas of rough skin
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Men and women aged 20 to 60 years at the time of informed consent.
2)Able to visit the testing site and undergo the required examinations on the designated dates.
3)Deemed eligible for participation in this study by the principal investigator.
Key exclusion criteria
1)Individuals with severe atopic dermatitis.
2)Individuals receiving hormone replacement therapy.
3)Individuals with a history of allergy to cosmetics or drugs, or those with sensitive skin.
4)Individuals who are pregnant, possibly pregnant, or breastfeeding.
5)Individuals with or suspected of having severe cardiac, renal, or hepatic impairment, or circulatory diseases.
6)Individuals who are currently undergoing or have undergone within the past 3 months treatments that may affect skin function, such as chemical peels, laser treatments, or the use of physician-prescribed medications including hydroquinone, high-concentration vitamin C, and retinoic acid on the forearm.
7)Individuals currently participating in other clinical trials.
8)Individuals with large scars, warts, or rashes on the medial aspect of the forearm.
9)Individuals deemed ineligible by the study investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Riichi |
| Middle name | |
| Last name | Takahashi |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
2440806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3612
takahashi_riichi@fancl.co.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Imai |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3539
Homepage URL
yoko1607@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
FANCL Corporation Ethics Committee
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
Tel
045-820-3565
hisaitou@fancl.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
| 2025 | Year | 06 | Month | 20 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066540
