Erythematotelangiectatic rosacea/Healthy subjects
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: A) Group with erythematotelangiectatic rosacea patients. (1) Patients aged 18 years or older at the time of informed consent. (2) Patients diagnosed with erythematotelangiectatic rosacea. (3) Patients with a Clinician Erythema Assessment (CEA) score of >= 1 on both cheeks. B) Healthy volunteer group Healthy control samples will be utilized from a separate ongoing study (Ref. jRCT1050250006).
Exclusion criteria
Exclusion criteria: A) Group with erythematotelangiectatic rosacea patients. (1) Patients with facial conditions that may interfere with the assessment of rosacea. (2) Patients with abnormal skin condition (such as scars or pigmentary disorders) that may interfere with the assessment at the sample collection site. (3) Patients with facial erythema other than rosacea. (4) Patients for whom sampling is deemed difficult due to wounds, excessive hair, or other conditions at the sample collection site, as determined by the principal investigator. (5) Patients with 4 or more inflammatory lesions (papules and pustules) on the face. (6) Patients who have received systemic antibacterial agents or immunosuppressive therapy (including corticosteroids) within 4 weeks prior to the sample collection date. (7) Patients who have applied any topical medications or quasi-drugs (such as over-the-counter antibacterial soaps) to the collection site within 1 week prior to the sample collection date. (8) Patients whose rosacea worsened or who developed rosacea-like dermatitis within 3 months prior to the sample collection date associated with the application of the following topical medications. (Topical corticosteroids, Topical tacrolimus, Topical JAK inhibitors, Topical PDE4 inhibitors) (9) Patients who initiated, switched, or changed the dose or route of administration of hormonal agents within 3 months prior to the sample collection date. (10) Patients who have undergone laser therapy, Intense Pulsed Light (IPL), or chemical peels on the face within 4 weeks prior to the sample collection date. (11) Patients who have undergone bleach bath treatment or entered a swimming pool or swum in the sea within 2 weeks prior to the sample collection date. (12) Patients who have showered, bathed, washed their face or shaved within 12 hours prior to the clinic visit on the sample collection date. (13) Patients who have applied skincare products (including facial wipes, body creams, etc.) to the face within 12 hours prior to the clinic visit on the sample collection date. (14) Patients who have applied makeup (including sunscreen) to the sample collection site on the day of sample collection. (15) Patients who have engaged in strenuous exercise or exercise that causes sweating on the day of sample collection. (16) Patients with a history or comorbidity of hepatic, renal, cardiac, cardiovascular, gastrointestinal, hematological diseases, or cancer that makes them unsuitable for participation in the study as determined by the investigator. (17) Patients who have participated in another clinical trial, post-marketing clinical study, or clinical research involving investigational products within 4 months prior to sample collection date, or who are currently participating in such studies. (18) Patients with a history of substance abuse or alcohol dependence. (19) Pregnant or breastfeeding women, or those who might be pregnant. (20) Patients considered inappropriate for the study by the principal investigator. B) Healthy volunteer group Healthy control samples will be utilized from a separate ongoing study (Ref. jRCT1050250006).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the causal relationship between disease pathogenesis and dysbiosis through analyses of skin microbiota and sebum samples from patients with erythematotelangiectatic rosacea and healthy controls. | — |
Contacts
Maruho Co., Ltd. Kyoto R&D Center