Rosacea
Conditions
Interventions
Test Product A group
Control
Sponsors
POLA Chemical Industries, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTaku Nishijo
POLA Chemical Industries, Inc. Frontier Research Center
Outcome results
None listed