NCT07343635招募中不适用
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 Fourth Affiliated Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2026年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Achievement of IGA treatment success at Week 12
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Achievement of IGA treatment success at Week 12
时间窗: 0 week、12 week
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
次要结局
- The proportion of subjects achieving successful IGA treatment(From baseline to weeks 4, 8, and 12)
- Dermatology Life Quality Index（DLQI）(Baseline, week 12)
- Change in facial erythema severity assessed by VISIA imaging system(From baseline to weeks 4, 8, and 12)
研究者
研究点 (1)
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