UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059494 |
|---|---|
| Receipt number | R000068050 |
| Scientific Title | Study on the Mechanisms Underlying Sensitive Skin with Rosacea-like Symptoms |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/10/21 18:54:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the Mechanisms Underlying Sensitive Skin with Rosacea-like Symptoms
Acronym
Study on the Sensitive Skin with Rosacea-like Symptoms
Scientific Title
Study on the Mechanisms Underlying Sensitive Skin with Rosacea-like Symptoms
Scientific Title:Acronym
Study on the Sensitive Skin with Rosacea-like Symptoms
Region
| Japan |
Condition
Condition
Rosacea
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the Mechanisms of Sensitive Skin with Rosacea-like Symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in Gene Expression Changes Among Groups and Temporal Gene Expression Dynamics
Differences in Gene Expression Changes Depending on the Applied Formulation and the Presence or Absence of Improvement in Sensitive Skin Symptoms
Key secondary outcomes
Correlation Between Gene Expression and Data Obtained from Facial Images, Various Measurements (Skin Biophysical Properties, Lactic Acid Stinging Test, Allergy Tests, etc.), and Questionnaire Responses
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Test Product A group
Interventions/Control_2
Control
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Select healthy Japanese women aged 30 to 49 years who meet all of the following criteria:
Individuals who have received an explanation of this study, fully understood its contents, and voluntarily agreed to participate by providing informed consent.
Individuals who either (a) are aware of having sensitive skin and have a medical history or self-recognition of rosacea, or (b) have no subjective symptoms of sensitive skin and no medical history or self-recognition of atopic dermatitis, rosacea, or acne (control group).
Individuals capable of completing consent forms and related documents.
Individuals who are able to visit the designated facility on the study day.
Key exclusion criteria
Individuals with scars or surgical marks around the cheek area (including under the eyes)
Individuals with a history of cosmetic medical procedures affecting facial shape (e.g., laser, photofacial, injection therapy, HIFU) or cosmetic surgery (e.g., incisions, thread lifts)
Individuals with excessive facial tanning
Individuals who regularly visit tanning salons
Individuals who have been extensively exposed to sunlight before the study date (e.g., continuous outdoor sports)
Individuals expected to experience severe hay fever before the study date (requiring medical treatment)
Individuals who habitually consume excessive amounts of alcohol
Individuals expected to use topical corticosteroids (steroids) or immunomodulators (e.g., tacrolimus) on the face before the study date
Individuals undergoing hormone replacement therapy
Individuals taking oral contraceptives
Individuals with allergies to disinfectant alcohol or latex
Pregnant or breastfeeding individuals
Individuals currently participating in other clinical studies
Individuals with cold symptoms or a fever of 37.5C or higher
Individuals with a history of severe hepatic disorder, renal disorder, or myocardial infarction
Individuals with severe anemia
Individuals who have experienced fainting or malaise during blood collection
Individuals with a keloid predisposition (those whose scars tend to become raised and red, resembling a worm-like swelling, and heal poorly)
Individuals with diabetes mellitus
Individuals taking antithrombotic medications
Any other individuals deemed inappropriate for participation by the principal investigator involved in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yamasaki |
Organization
General Incorporated Association Astronauts- ALOOP CLINIC & LAB
Division name
General Incorporated Association Astronauts- ALOOP CLINIC & LAB
Zip code
104-0061
Address
1-7-7 Ginza, Chuo-ku, Tokyo - POLA Ginza Building
TEL
0120-506-182
k-yamasaki@aloop.clinic
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Nishijo |
Organization
POLA Chemical Industries, Inc.
Division name
Frontier Research Center
Zip code
244-0812
Address
560 Kashio-cho, Totsuka-ku, Yokohama
TEL
045-826-7232
Homepage URL
t-nishijo@pola.co.jp
Sponsor or person
Institute
POLA Chemical Industries, Inc.
Institute
Department
Personal name
Funding Source
Organization
POLA Chemical Industries, Inc.
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
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel
03-5575-5862
c-irb_ug@neues.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
| 2025 | Year | 11 | Month | 10 | 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 | 10 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068050
