Erythematotelangiectatic RosaceaNCT07343635
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 study testing Doxycycline, Hydroxychloroquine and Tofacitinib in people with Erythematotelangiectatic Rosacea, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Erythematotelangiectatic Rosacea
- What is being tested?
- Doxycycline, Hydroxychloroquine and Tofacitinib
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Liu, 0579-89979999, 2197055@zju.edu.cn
About this study
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
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
- Conditions
- Erythematotelangiectatic Rosacea
- Being tested
- Doxycycline, Hydroxychloroquine, Tofacitinib, Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 100 mg orally once daily
Hydroxychloroquine 200 mg orally twice daily.
TofacitinibDrug
Tofacitinib 5mg orally twice daily.
Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)Device
Topical application of Hirudoid followed by yellow light therapy (wavelength 590 nm, duration 20 minutes per session, once weekly)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants receive doxycycline combined with hydroxychloroquine. Receives: Drug: Doxycycline; Drug: Hydroxychloroquine |
| Tofacitinib group | Active comparator | Participants receive doxycycline combined with tofacitinib. Receives: Drug: Doxycycline; Drug: Tofacitinib |
| Anti-inflammation Treatment and Tofacitinib group | Experimental | Participants receive doxycycline and tofacitinib combined with anti-inflammatory treatment. Receives: Drug: Doxycycline; Drug: Tofacitinib; Device: Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 week、12 week
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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.
Measured: From baseline to weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythematotelangiectatic RosaceaStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343635
- Sponsor's protocol ID
- KY-2025-274
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07343635
- Acronym / sponsor ID
- KY-2025-274
- Conditions
- Erythematotelangiectatic Rosacea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Doxycycline, Drug: HydroxychloroquineParticipants receive doxycycline combined with hydroxychloroquine. |
| Tofacitinib group | Active comparator | Drug: Doxycycline, Drug: TofacitinibParticipants receive doxycycline combined with tofacitinib. |
| Anti-inflammation Treatment and Tofacitinib group | Experimental | Drug: Doxycycline, Drug: Tofacitinib, Device: Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy)Participants receive doxycycline and tofacitinib combined with anti-inflammatory treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.).
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineDoxycycline 100 mg orally once daily | Drug | Anti-inflammation Treatment and Tofacitinib group, Control group, Tofacitinib group |
| HydroxychloroquineHydroxychloroquine 200 mg orally twice daily. | Drug | Control group |
| TofacitinibTofacitinib 5mg orally twice daily. | Drug | Anti-inflammation Treatment and Tofacitinib group, Tofacitinib group |
| 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) | Device | Anti-inflammation Treatment and Tofacitinib group |
Primary outcome
Achievement of IGA treatment success at Week 12
Time frame: 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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline, Hydroxychloroquine and Tofacitinib in people with Erythematotelangiectatic Rosacea, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu (0579-89979999, 2197055@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of IGA treatment success at Week 12 (time frame: 0 week、12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.