The efficacy and safety of anti-inflammation treatment (Hirudoid introduction followed by yellow light therapy) combined with tofacitinib and doxycycline in Chinese adult patients with mild to moderate erythematous telangiectatic rosacea: A prospective parallel controlled single-blind cohort study
The subjects are male or female, aged 18 to 70 years (inclusive); they voluntarily participate in this study and sign the informed consent form.
They are diagnosed with erythematous telangiectatic rosacea, meeting the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Rosacea (2021)".
At screening and baseline, the IGA score is 2 (mild) or 3 (moderate).
The subjects agree not to use any other rosacea treatment drugs (prescription or over-the-counter) during the study period.
Diagnosed as papulopustular, hypertrophic, ocular rosacea or other special types of rosacea
Other facial skin diseases that were active during the screening period or baseline may interfere with the efficacy/safety assessment of erythematous vasodilating rosacea, including but not limited to perioral dermatitis, facial keratosis, seborrheic dermatitis, and acne vulgaris. If the above-mentioned skin diseases were in clinical remission both during the screening period and at baseline, and the investigators determined that they would not affect the assessment of this study, they could be included.
Subjects who have underlying known diseases or medical conditions, or who have undergone major surgeries within the six months prior to screening, where, based on the researcher's judgment, the subjects are at risk (such as cancer, leukemia or cachexia in the blood system);
During the screening period or at baseline, researchers evaluate abnormal laboratory test results with significant clinical significance;
Parallel
Doxycycline
DrugDoxycycline 100 mg orally once daily
Hydroxychloroquine
DrugHydroxychloroquine 200 mg orally twice daily.
Tofacitinib
DrugTofacitinib 5mg orally twice daily.
Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)
DeviceTopical application of Hirudoid followed by yellow light therapy (wavelength 590 nm, duration 20 minutes per session, once weekly)
Achievement of IGA treatment success at Week 12
Achievement of IGA treatment success(IGA = 0 or 1, and the proportion of subjects with an improvement of ≥2 grades from baseline) at Week 12
The proportion of subjects achieving successful IGA treatment
The proportion of subjects achieving successful IGA treatment (IGA = 0 or 1, and the proportion of subjects with an improvement of ≥2 grades from baseline)
Dermatology Life Quality Index（DLQI）
Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)
Change in facial erythema severity assessed by VISIA imaging system
Facial erythema severity will be quantitatively assessed using the VISIA imaging system. Standardized facial photographs will be obtained at each visit, and changes in erythema severity from baseline will be evaluated using VISIA-derived analysis.
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