UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060768 |
|---|---|
| Receipt number | R000069516 |
| Scientific Title | Evaluation Study of a Formulation on Aging-Related Skin Parameters |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/02/26 23:40:20 |
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Basic information
Public title
Evaluation Study of a Formulation on Aging-Related Skin Parameters
Acronym
Evaluation Study of a Formulation on Aging-Related Skin Parameters
Scientific Title
Evaluation Study of a Formulation on Aging-Related Skin Parameters
Scientific Title:Acronym
Evaluation Study of a Formulation on Aging-Related Skin Parameters
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the topical test product on aging-related skin conditions, particularly facial redness, in healthy Japanese women with subjective awareness of facial redness, following 8 weeks of application.
Efficacy will be assessed at Week 0 (baseline), Week 4, and Week 8, and compared with placebo using a split-face design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin color parameters (L* and a* values)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
topical test product.The topical test product will be applied to one side of the face for 8 weeks.
Interventions/Control_2
The placebo product will be applied to the contralateral side of the face.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Subjects meeting all of the following criteria will be included:
1. Healthy Japanese females aged 30 to 60 years at the time of informed consent
2. Subjects who are able to understand the study procedures and provide written informed consent
3. Subjects who are able to use the investigational product as instructed during the study period
4. Subjects who have subjective awareness of facial redness
Key exclusion criteria
Subjects meeting any of the following criteria will be excluded:
1. Subjects with any dermatological condition at the study site or systemic condition that may affect study evaluation
2. Subjects with a history of medication use, medical treatment, or medical/cosmetic procedures that may affect the study results
3. Subjects with a history of severe hypersensitivity or allergy to drugs, cosmetics, or related products
4. Subjects who are pregnant, breastfeeding, or possibly pregnant
5. Subjects who are currently participating in another clinical trial or planning to participate in another clinical trial
6. Subjects who are likely to experience significant changes in living environment or external factors (e.g., ultraviolet exposure) during the study period that may affect the evaluation
7. Subjects who are unable to comply with study procedures or provide adequate cooperation
8. Subjects who are judged by the principal investigator to be unsuitable for participation for any reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Suenobu |
Organization
Rohto Pharmaceutical Co., Ltd.
Division name
Fundamental Technology Research Department
Zip code
544-8666
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka Japan
TEL
06-6758-1231
suenobunoriko@rohto.co.jp
Public contact
Name of contact person
| 1st name | Eiko |
| Middle name | |
| Last name | Uno |
Organization
Rohto Pharmaceutical Co., Ltd.
Division name
Fundamental Technology Research Department
Zip code
619-0216
Address
6-5-4 Kunimidai, Kizugawa City, Kyoto, Japan
TEL
0774-71-8774
Homepage URL
unoe@rohto.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
701 Clinical Ethics Committee
Address
5F,OakOtsuka Bld. 1-13-4 Kita Otsuka, Toshima-ku, Tokyo
Tel
03-5832-5008
sa@701research.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2026-A009
Org. issuing International ID_1
701 Research Inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社セブンオーワンリサーチ（701 Research Inc.）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | 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
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
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069516
