Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059494) titled 'Study on the Mechanisms Underlying Sensitive Skin with Rosacea-like Symptoms' on Nov. 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - POLA Chemical Industries, Inc.

Condition: Condition - Rosacea Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Elucidation of the Mechanisms of Sensitive Skin with Rosacea-like Symptoms Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Test Product A group Interventions/Control_2 - Control

Eligibility: Age-lower limit - 30 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 Size - 50

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068050

Disclaimer: Curated by HT Syndication.