UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060798 |
|---|---|
| Receipt number | R000069545 |
| Scientific Title | A prospective, randomized, double-blind, vehicle-controlled, within-subject (contralateral) study evaluating changes in eyelash length following topical application of kukui nut oil (Aleurites moluccanus seed oil) in healthy adults |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/04 11:16:12 |
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Basic information
Public title
Evaluation of the kukui nut oil (Aleurites moluccanus seed oil) for eyelash length in healthy adults
Acronym
Evaluation of the kukui nut oil for eyelash length in healthy adults
Scientific Title
A prospective, randomized, double-blind, vehicle-controlled, within-subject (contralateral) study evaluating changes in eyelash length following topical application of kukui nut oil (Aleurites moluccanus seed oil) in healthy adults
Scientific Title:Acronym
Evaluation of changes in eyelash length following topical application of kukui nut oil
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Despite its traditional application for hair growth in Polynesia, there is a paucity of scientific data regarding the impact of kukui nut oil (Aleurites moluccanus seed oil) on human eyelashes. This study investigates the effect of topical kukui nut oil application on eyelash elongation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in eyelash length
Key secondary outcomes
Subjects' subjective evaluation of eyelash growth effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Topical application of eyelash serum containing 0.1% kukui nut oil, applied twice daily for 4 weeks to the randomized eyelash side (left or right).
Interventions/Control_2
Topical application of vehicle serum without active ingredient, applied twice daily for 4 weeks to the contralateral eyelash side.
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese women aged 20 to 49 at the time of consent acquisition
2) Individuals who perceive their eyelash length as average (neither extremely long nor extremely short)
3) Individuals who can agree not to use mascara, eyelash curlers, or false eyelashes during the trial period
4) Individuals who can agree not to undergo cosmetic procedures on their eyelashes, such as eyelash extensions or eyelash perms, during the trial period
5) Individuals not currently wearing false eyelashes, or who last wore false eyelashes at least 2 weeks prior
6) Individuals not currently wearing eyelash extensions, or who last had eyelash extensions applied at least 4 weeks prior
Key exclusion criteria
1) Individuals with permanent makeup applied to the eyeliner area
2) Individuals who are pregnant, may be pregnant, or are breastfeeding
3) Individuals who may exhibit allergic reactions to any component of the test product
4) Individuals participating in other clinical trials
5) Individuals taking supplements or medications that may affect the efficacy of the test product (e.g., glaucoma medications, eyelash hypotrichosis treatments)
6) Individuals currently receiving treatment at a dermatology or ophthalmology clinic
7) Individuals suspected of having, or with a history of, severe digestive disorders, liver disease, kidney disease, cardiovascular disease, blood disorders, endocrine disorders, or malignant neoplasms
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Fumitaka |
| Middle name | |
| Last name | Fujita |
Organization
Mandom Corporation
Division name
Advanced Technology Institute
Zip code
565-0871
Address
1-6 Yamadaoka, Suita City, Osaka, Osaka University MA-T Co-Creation Center (Anzu-no Mori)3F
TEL
06-6105-5785
fumitaka.fujita@mandom.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hara |
Organization
Mandom Corporation
Division name
Advanced Technology Institute
Zip code
565-0871
Address
1-6 Yamadaoka, Suita City, Osaka, Osaka University MA-T Co-Creation Center (Anzu-no Mori)3F
TEL
06-6105-5785
Homepage URL
takeshi.hara@mandom.com
Sponsor or person
Institute
Mandom Corporation
Institute
Department
Personal name
Takeshi Hara
Funding Source
Organization
Mandom Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mandom Corporation
Address
5-12, Juniken-cho, Chuo-ku, Osaka 540-8530, Japan
Tel
06-6767-5001
takeshi.hara@mandom.com
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
株式会社SOUKEN（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
Eyelash growth was observed in the 0.1% kukui nut oil application group. Subjective assessments of eyelash length, thickness, and volume improved.
Results date posted
| 2026 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 03 | Day |
Baseline Characteristics
Currently, various eyelash serums are available on the market, but few products possess a high efficacy for promoting eyelash growth. Consumers are seeking eyelash serums that deliver noticeable growth effects.
Participant flow
During subject recruitment, a questionnaire was administered. Individuals who self-reported meeting the "selection criteria" and did not violate the "exclusion criteria (based on subject self-report)" underwent a screening survey. Fifteen subjects meeting the "screening criteria" were selected and enrolled as subjects for the main trial.
Adverse events
Not observed.
Outcome measures
Eyelash length measured using VISIA Generation 7 (Canfield Scientific, Parsippany, NJ, USA).
Subjects' subjective assessment of eyelash growth effects based on questionnaires (Length, thickness, volume, reduced shedding).
Plan to share IPD
None.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069545
