Rosacea
Conditions
Interventions
Experimental Group:Apply 0.2% sirolimus gel thinly onto the areas of hypertrophic lesions twice daily, with the total daily dosage not exceeding 800mg.
Control Group:Apply placebo gel (sirolimus-free, with the same matrix components as those of the experimental group), with the administration method and dosage identical to the experimental group.
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years old, regardless of gender. 2. Conforms to the diagnostic criteria specified in the 2021 edition of the Guidelines for the Diagnosis and Treatment of Rosacea in China and is clinically diagnosed with phymatous rosacea. 3. Has not used any systemic medications (e.g., isotretinoin, antibiotics) or topical medications (e.g., azelaic acid, ivermectin) for the treatment of rosacea within 1 month prior to enrollment. 4. Voluntarily signs the informed consent form and is able to cooperate with the follow-up visits and various assessments throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Subjects with hypersensitivity to sirolimus or any component of the gel matrix. 2. Subjects complicated with other facial dermatoses (e.g., atopic dermatitis, psoriasis) or skin infections. 3. Pregnant or lactating women, or those planning to become pregnant during the study period. 4. Subjects with severe hepatic or renal insufficiency, immunocompromise (e.g., autoimmune diseases, history of organ transplantation) or a history of malignant tumors. 5. Subjects who have received facial photoelectric therapy, surgical treatment or other interventions that may affect lesion assessment within 3 months prior to enrollment. 6. Subjects who are unable to cooperate with AI image acquisition or have facial anatomical abnormalities that interfere with assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AI-driven Phymatous Rosacea Score (AI-PRS);Phymatous volume;Phymatous thickness;Number of phymatous nodules;Erythema area; | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's Global Assessment (IGA);Clinician's Erythema Assessment (CEA);Dermatology Life Quality Index (DLQI) score;Patient satisfaction; | — |
Countries
China
Contacts
Public ContactWu Jiawen
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed