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

Official title

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

Overview

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

Interventions

• Drug Doxycycline
  Doxycycline 100 mg orally once daily
• Drug Hydroxychloroquine
  Hydroxychloroquine 200 mg orally twice daily.
• Drug Tofacitinib
  Tofacitinib 5mg orally twice daily.
• Device Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)
  Topical application of Hirudoid followed by yellow light therapy (wavelength 590 nm, duration 20 minutes per session, once weekly)

Primary outcome measures

• Achievement of IGA treatment success at Week 12 [Time frame: 0 week、12 week]

Secondary outcome measures (3)

• The proportion of subjects achieving successful IGA treatment [Time frame: From baseline to weeks 4, 8, and 12]
• Dermatology Life Quality Index（DLQI） [Time frame: Baseline, week 12]
• Change in facial erythema severity assessed by VISIA imaging system [Time frame: From baseline to weeks 4, 8, and 12]

Eligibility criteria

Inclusion criteria

• 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.
• The subjects are willing to minimize external factors that may trigger rosacea (such as spicy food, alcoholic beverages, prolonged sun exposure, etc.).
• 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

• 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;
• Those who have received LED light therapy for their faces in the past two weeks;
• 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;
• 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;
• 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 macrolides, metronidazole), high-concentration vitamin A (10,000 units per day), anti-pruritus drugs (such as antihistamines), etc.
• Use drugs that cause acne-like rashes simultaneously (such as azathioprine, haloperidol, halogens, lithium, systemic corticosteroids, phenytoin sodium, phenobarbital, testosterone, anabolic steroids, isoniazid);
• 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;
• 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;
• 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;
• Female subjects who plan to become pregnant or breastfeed during the study period;
• Those who are sensitive to light or use photosensitive drugs;
• People who are allergic to Hirudoid, tofacitinib, doxycycline, hydroxychloroquine or their ingredients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu

Identifiers

NCT: NCT07343635 · KY-2025-274

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗