UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062647 |
|---|---|
| Receipt number | R000071674 |
| Scientific Title | An Intra-Individual Randomized Controlled Trial of a Skincare Cream in Japanese Women with Solar Lentigines |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/19 11:54:57 |
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Basic information
Public title
Efficacy study of the skincare cream
Acronym
Efficacy study of the skincare cream
Scientific Title
An Intra-Individual Randomized Controlled Trial of a Skincare Cream in Japanese Women with Solar Lentigines
Scientific Title:Acronym
An Intra-Individual Randomized Controlled Trial of a Skincare Cream
Region
| Japan |
Condition
Condition
Solar Lentigines
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous application of a skincare cream on solar lentigines
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin color (L*)
Key secondary outcomes
Skin color (a*, b*)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
The skincare cream is applied to one side of the face twice daily for 8 weeks.
Interventions/Control_2
The skincare cream (Placebo) is applied to one side of the face twice daily for 8 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Japanese women aged 30 to 59 years
(2) Subjects with specific spots (solar lentigines) on both cheeks
(3) Subjects with no plans for excessive sun exposure during the study period
(4) Subjects with a simple post-cleansing skincare routine
Key exclusion criteria
(1) Subjects with skin factors in the evaluation area that may affect the study results
(2) Subjects who routinely use creams, gels, serums, facial masks, oils, or liquid foundations on the evaluation area as part of their daily skincare
(3) Subjects continuously using skincare products, cosmetics, quasi-drugs, or health foods on the evaluation area that claim efficacy similar to or related to the study's primary endpoint (e.g., skin-brightening effects)
(4) Subjects who have changed or started using new health foods, basic skincare products applied to the evaluation area, or sunscreens within the past 4 weeks
(5) Subjects who have been exposed to UV radiation beyond normal daily life (e.g., prolonged outdoor work, exercise, swimming, or outdoor leisure activities) within the past 4 weeks, or plan to be exposed during the study period
(6) Subjects working night shifts or rotating shifts
(7) Subjects receiving medical treatment/prevention at a healthcare facility at the time of informed consent, or those deemed to require medical treatment
(8) Subjects with severe diseases involving glucose metabolism, lipid metabolism, hepatic, renal, cardiac, cardiovascular, respiratory, endocrine, immune, or nervous systems
(9) Subjects with a history of alcohol or drug dependence
(10) Subjects at risk of developing allergic reactions to cosmetics or foods
(11) Subjects who have participated in other human/clinical trials within the past 4 weeks, or who plan to participate in other trials during the study period
(12) Subjects judged to be ineligible for study participation by the principal investigator (or study director)
(13) Subjects who themselves, or whose cohabiting family members, work for a cosmetics company
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Nakamura |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Beauty Care Development Group, Healthcare Product Development Department, R&D Headquarters
Zip code
562-0029
Address
4-1-66 Saito Aokita, Minoh, Osaka, Japan
TEL
070-1296-2219
yuk.nakamura@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Yamamura |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Beauty Care Development Group, Healthcare Product Development Department, R&D Headquarters
Zip code
562-0029
Address
4-1-66 Saito Aokita, Minoh, Osaka
TEL
080-9455-2764
Homepage URL
t.yamamura@kobayashi.co.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical 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
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
06-6882-1130
ethics_board@drc-web.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
260326-005
Org. issuing International ID_1
DRC Co., Ltd.
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 | 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 | 08 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 27 | 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 | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071674
