UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060578 |
|---|---|
| Receipt number | R000068925 |
| Scientific Title | Evaluation of Safety and Skin Condition Following Use of Test Cosmetics |
| Date of disclosure of the study information | 2026/02/04 |
| Last modified on | 2026/01/31 08:07:37 |
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Basic information
Public title
Evaluation of Safety and Skin Condition Following Use of Test Cosmetics
Acronym
Evaluation of Safety and Skin Condition Following Use of Test Cosmetics
Scientific Title
Evaluation of Safety and Skin Condition Following Use of Test Cosmetics
Scientific Title:Acronym
Evaluation of Safety and Skin Condition Following Use of Test Cosmetics
Region
| Japan |
Condition
Condition
acne vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the safety and skin condition of test cosmetics with different formulations when applied to one side of the face (left or right) for 12 weeks in subjects with mild to moderate acne vulgaris.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Safety
1) Adverse events
2) Side effects
3) Skin findings
4) Subjective symptoms
5) Number of rashes
Key secondary outcomes
*Skin condition
1) Stratum corneum moisture content
2) Trans epidermal water loss
3) Sebum level
4) Color difference
5) Skin condition score
6) Average pore area, average pore sagging rate
7) Subject self-assessment
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the test product to the entire designated side of the face twice daily after washing in the morning and evening. Continue this for 12 weeks.
Interventions/Control_2
Apply the control product to the entire designated side of the face twice daily after washing in the morning and evening. Continue this 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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 18 to 39 years at the time of consent acquisition
2) Patients with mild to moderate acne vulgaris
3) Individuals with 10 or more inflammatory lesions on the face, up to approximately 40 lesions. No more than 2 nodules/cysts. Lesion counts on both sides are similar.
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this study.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this study by the principal investigator.
Key exclusion criteria
Individuals
1) currently receiving acne treatment with prescription medications from a medical institution.
2) with clinically abnormal facial skin conditions that could affect the objectives of this study.
3) with acne conglobata, acne fulminans, or secondary acne.
4) with underlying conditions or skin symptoms requiring local or systemic therapy that may affect this study.
5) diagnosed with polycystic ovary syndrome (PCOS).
6) with a history of hypersensitivity to ingredients in this trial cosmetic or to cosmetics in general.
7) who changed their facial cleansers or skincare products within the past month.
8) who received, or require, specified medications or therapies during the defined period.
A) Topical agents and procedures applied to the study site and head.
I. Topical agents
i. who used the following products within 4 weeks.:
-Formulations containing retinoids
-Formulations containing azelaic acid
ii. who used the following products within 2 weeks.:
-Acne treatments such as antibacterial agents and anti-inflammatory agents
-Products containing benzoyl peroxide
-Adrenal corticosteroids
-Products considered to have a keratolytic effect
II. Procedures, etc.
i. who received the following procedures within 4 weeks:
-Surgery and cosmetic procedures such as chemical peels, laser treatments, phototherapy, or esthetic treatments.
B) Systemic medications, etc.
I. who used the following products within 12 weeks.:
-Preparations containing retinoids
II. who used the following products within 4 weeks.:
-Other acne treatments
-Adrenal corticosteroids
-Preparations affecting sex hormones
-Traditional Chinese medicine preparations considered effective for acne
9) with severe cardiac, renal, hepatic, respiratory, circulatory, or immunodeficiency conditions that make them unsuitable for the study.
10) who are pregnant, breastfeeding, may be pregnant, or plan to become pregnant during the study.
11) considered unsuitable for the study by the investigator team.
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
Basic Research and Development Division, Health / Skin Science Business Planning Division
Zip code
544-8666
Address
1-8-1,Tatsumi-nishi,Ikuno-ku, Osaka 544-8666, Japan
TEL
06-6758-1231
hsrpd@rohto.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Rohto 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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 | 02 | Month | 04 | 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 | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 15 | 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 | 04 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068925
