Rosacea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged =18 years (inclusive). 2.Fitzpatrick skin phototype II–IV. 3.Clinically confirmed erythematotelangiectatic rosacea (ETR) subtype I per National Rosacea Society Expert Committee (NRSEC) classification, with Clinical Erythema Assessment (CEA) score 2–3. 4.Subjects expressing desire for rosacea improvement. 5.Voluntary provision of signed informed consent and willingness to complete protocol-specified follow-ups.
Exclusion criteria
Exclusion criteria: 1.History of severe diseases in major organs or active autoimmune diseases. 2.Use of rosacea-related medications (oral/topical antibiotics, azelaic acid, vasoconstrictors, etc.) within 1 month prior to screening or planned during the study. 3.Presence of scars, dermatoses (e.g., active infection [herpes simplex], unhealed wounds, progressive dermatoses [vitiligo, psoriasis], or facial inflammatory conditions [seborrheic dermatitis, acne]) in the treatment area that may interfere with efficacy evaluation. 4.Planned or recent interventions affecting study outcomes: a. Procedures within 6 months pre-screening or planned during the study: lasers, light therapies, radiofrequency, dermabrasion, medium/deep chemical peels, degradable fillers (hyaluronic acid, collagen) b. Procedures within 12 months pre-screening or planned during the study: semi-permanent dermal fillers (calcium hydroxylapatite, poly-L-lactic acid) c. Facial treatments pre-screening or planned during the study: silicone implants, fat grafts, thread lifts, permanent fillers (polymethylmethacrylate). 5.History of severe allergies, atopy, planned desensitization therapy, or hypersensitivity to study-related components (hyaluronic acid, L-carnosine, vitamin B2, lidocaine/amide anesthetics). 6.Pregnancy, lactation, planned pregnancy (or males unwilling to use contraception), or positive pregnancy test at screening. 7.History of hypertrophic scars or keloid tendency. 8.Participation in other clinical trials within 30 days pre-screening. 9.Other systemic conditions deemed unsuitable for participation by investigators. 10.Bleeding tendency or current use of anticoagulants/therapies prolonging clotting time (unwilling or unable to discontinue). 11.Inability to communicate or comply with instructions. 12.Other investigator-determined contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with rosacea improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with rosacea improvement; | — |
Countries
China
Contacts
Peking University Shenzhen Hospital