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

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 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

Study Overview

• Status: Recruiting
• Conditions: Erythematotelangiectatic Rosacea
• Intervention / Treatment: Drug: Doxycycline; Drug: Hydroxychloroquine; Drug: Tofacitinib; Device: Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu; Phone Number: 0579-89979999; Email: 2197055@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Liu; Phone Number: 0579-89979999; Email: 2197055@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Participants receive doxycycline combined with hydroxychloroquine.	Drug: Doxycycline; Doxycycline 100 mg orally once daily; Drug: Hydroxychloroquine; Hydroxychloroquine 200 mg orally twice daily.
Active Comparator: Tofacitinib group; Participants receive doxycycline combined with tofacitinib.	Drug: Doxycycline; Doxycycline 100 mg orally once daily; Drug: Tofacitinib; Tofacitinib 5mg orally twice daily.
Experimental: Anti-inflammation Treatment and Tofacitinib group; Participants receive doxycycline and tofacitinib combined with anti-inflammatory treatment.	Drug: Doxycycline; Doxycycline 100 mg orally once 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0 week、12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From baseline to weeks 4, 8, and 12
Dermatology Life Quality Index（DLQI）	Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)	Baseline, week 12
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.	From baseline to weeks 4, 8, and 12

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Rosacea; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthacenes; Tetracyclines; Quinolines; Aminoquinolines; Chloroquine; Hydroxychloroquine; Doxycycline; tofacitinib
• Other Study ID Numbers: KY-2025-274

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No