UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062703 |
|---|---|
| Receipt number | R000057814 |
| Scientific Title | Study to evaluate the effect of peeling cosmetics containing phytic acid on skin |
| Date of disclosure of the study information | 2026/08/30 |
| Last modified on | 2026/08/26 20:15:12 |
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Basic information
Public title
Study to evaluate the effect of peeling cosmetics containing phytic acid on skin
Acronym
Study to evaluate the effect of peeling cosmetics containing phytic acid on skin
Scientific Title
Study to evaluate the effect of peeling cosmetics containing phytic acid on skin
Scientific Title:Acronym
Study to evaluate the effect of peeling cosmetics containing phytic acid on skin
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the efficacy of a peeling agent containing phytic acid on the skin of healthy men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sebum level
Key secondary outcomes
Wrinkle score, Texture score, Red area score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants 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
Subjects will apply phytic acid formula to the entire face, then rinse off the product thoroughly and apply a moisturizing gel, once a day for 12 weeks.
Interventions/Control_2
Subjects will apply placebo formula to the entire face, then rinse off the product thoroughly and apply a moisturizing gel, once a day for 12 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
-Men between the ages of 20 and 60 years old.
-Who can be confirmed good health and free from chrocic physical disease by medical interview.
-Who not be using any cosmetics with medicinal effects.
-Who have been fully informed of the purpose and content of the study, have the ability to consent, and be able to voluntarily agree to participate in the study in writing upon full understanding of the study.
-Who be able to come to the laboratory on the designated examination date and be able to undergo the examination.
-Who be approved participate in the study by investigator.
Key exclusion criteria
-Who are currently undergoing drug treatment for some disease.
-Who have serious skin diseases such as dermatitis.
-Who cannot intentionally refrain from being exposed to direct sunlight during the study period, for example, by sunbathing.
-Who show statistical outliers in measurements related to the primary and secondary outcomes of the study.
Who with allergies (to pharmaceuticals or products related to test materials).
-Who have a current or past habit of continuous ingestion or application of drugs claiming to improve the skin.
-Who use cosmetics that have a strong effect on the skin (the investigator will determine)
-Who are deemed inappropriate for this study by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Nakamura |
Organization
Tsuno Rice Fine Chemicals Co., LTD
Division name
Research and Development
Zip code
649-7194
Address
2283, Chonomachi, Ito-gun, Katsuragi-cho, Wakayama
TEL
0736-26-5032
Nakamura.toshi@tsuno.co.jp
Public contact
Name of contact person
| 1st name | Mizuka |
| Middle name | |
| Last name | Kobayashi |
Organization
Tsuno Rice Fine Chemicals Co., LTD
Division name
Research and Development
Zip code
649-7194
Address
2283, Chonomachi, Ito-gun, Katsuragi-cho, Wakayama
TEL
0736-26-5032
Homepage URL
Nakamura.toshi@tsuno.co.jp
Sponsor or person
Institute
Tsuno Rice Fine Chemicals Co., LTD
Institute
Department
Personal name
Funding Source
Organization
Self
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
Tsuno Rice Fine Chemicals Co., LTD
Address
2283, Chonomachi, Ito-gun, Katsuragi-cho, Wakayama
Tel
0736-26-5032
Nakamura.toshi@tsuno.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
| 2026 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Nothing
Publication of results
Published
Result
URL related to results and publications
Nothing
Number of participants that the trial has enrolled
39
Results
Primary Outcomes
Sebum production: In Week 4, a statistically significant difference was observed between the phytic acid group and the placebo group.
Secondary outcomes
Results date posted
| 2026 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Because data analysis and content verification took longer than expected.
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 31 | Day |
Baseline Characteristics
39 healthy men in their 20s to 50s (19 in the placebo group, 18 in the phytic acid group)
Placebo group: 39.1 years old
Phytic acid group: 38.8 years old
Participant flow
Recruited 41 participants.
Included 39 participants who did not meet the exclusion criteria.
Divided them into two groups with balanced means for age, primary outcomes score, and secondary outcomes score, and began the trial.
Two participants in the placebo group dropped out because they did not complete the required number of sessions.
The final analysis was conducted with 18 participants in the placebo group and 19 in the phytic acid group.
Adverse events
Nothing
Outcome measures
Sebum levels, skin viscoelasticity, melanin index, wrinkle score, skin texture score, and redness score based on image analysis
Skin condition based on the VAS questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057814
