Rosacea
Conditions
Interventions
Experimental Group:Yellow light therapy (wavelength 590nm, time 20 minutes, once a week) after introduction of Hirudoid, combined with tofacitinib 5mg orally twice daily
Control group:Tofacitinib 5mg orally twice daily
Sponsors
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects are male or female, aged 18 to 70 years (inclusive); they voluntarily participate in this study and sign the informed consent form. 2. They are diagnosed with erythematous telangiectatic rosacea, meeting the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Rosacea (2021)". 3. At screening and baseline, the IGA score is 2 (mild) or 3 (moderate). 4. The subjects agree not to use any other rosacea treatment drugs (prescription or over-the-counter) during the study period. 5. The subjects are willing to minimize external factors that may trigger rosacea (such as spicy food, alcoholic beverages, prolonged sun exposure, etc.). 6. The subjects (including their partners) agree that they have no plans to conceive within 3 months after signing the informed consent form until the end of the last treatment and are willing to take effective contraceptive measures voluntarily.
Exclusion criteria
Exclusion criteria: 1. Diagnosed as papulopustular, hypertrophic, ocular rosacea or other special types of rosacea 2. 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. 3. 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); 4. During the screening period or at baseline, researchers evaluate abnormal laboratory test results with significant clinical significance; 5. Those who have received LED light therapy for their faces in the past two weeks; 6. Those who have received laser, intense pulsed light (IPL), fractional microneedle radiofrequency treatment, CO2 exfoliating fractional laser treatment, electrocoagulation, dermabrasion, chemical peels, or any facial procedures (such as Thermage, etc.) for facial treatment in the past 6 weeks; 7. Facial active infections who are currently receiving or require systemic treatment (systemic antibiotics, antifungal, antiviral drugs) - including bacterial pustules, fungal folliculitis, herpeder-like skin lesions and massive proliferation of Demodex mites; 8. Local/systemic treatment that did not complete an adequate elution period before baseline, including: Glucocorticoids (corticosteroids), calcineurin inhibitors (such as tacrolimus, pimecrolimus), Janus kinase inhibitors, epidermal growth factors (such as commercially available repair dressings containing recombinant human EGF), acne treatment drugs (such as azelaic acid, retinoids, benzoyl peroxide, traditional Chinese medicine/Chinese patent medicine treatment), Such as tanshinone, metronidazole tablets, etc.), immunomodulators, topical astringents/exfoliating products, antibiotics (such as tetracyclines, macrolides, metronidazole), high-concentration vitamin A (10,000 units per day), anti-pruritus drugs (such as antihistamines), etc. 9. Use drugs that cause acne-like rashes simultaneously (such as azathioprine, haloperidol, halogens, lithium, systemic corticosteroids, phenytoin sodium, phenobarbital, testosterone, anabolic steroids, isoniazid); 10. Those who have used astringents/exfoliating products (cleansing or exfoliating products containing salicylic acid or alcohol) within the past 2 days or are planned to use them during the study period; 11. The subject has a history of alcohol abuse (drinking more than 14 units) within the past 2 years or a history of drug abuse within the past 5 years; 12. Individuals infected with human immunodeficiency virus (HIV), those in the active stage of hepatitis C virus (HCV) infection (positive for anti-HCV), or those in the active stage of hepatitis B virus (HBV) infection (HBV-DNA > 2000IU/mL or 104 copies /ml), or those with positive Treponema pallidum antibodies showing an active stage of infection; 13. Female subjects who plan to become pregnant or breastfeed during the study period; 14. Those who are sensitive to light or use photosensitive drugs; 15.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of IGA treatment success at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving successful IGA treatment;VISIA photo;DLQI;Morphology of keratinocytes; | — |
Countries
China
Contacts
Public ContactLiu Lunfei
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed