RosaceaPhase 4NCT06307288
Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea
A Phase 4 study testing minocycline and tranilast in people with Rosacea, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rosacea
- What is being tested?
- minocycline and tranilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and nonpregnant females, aged 18-60 years old;
- Diagnosed with erythematotelangiectatic or papulopustular rosacea, with an investigator' s global assessment of 3-5;
- Patients with good cognitive function and normal mental status;
- Patients with good communication skills;
- Voluntary participation in the study and signing of informed consent form.
Who cannot join
- Allergy to any component of tranilast capsules;
- Allergy to any component of minocycline capsules;
- History of systemic medication for rosacea treatment within the past month;
- Pregnancy or lactation;
- Presence of severe primary diseases in addition to rosacea, such as cardiovascular system, cerebrovascular system, digestive system, urinary system, hematopoietic system diseases, or systemic failure.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xi'an Jiaotong Universi
Xi'an, Shaanxi, 710000
About this study
Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients.
Read the detailed description
Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. In the skin, mast cells are located in the dermis near nerve endings and blood vessels, playing a crucial role in inflammatory responses. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. However, there is currently a lack of clinical studies evaluating the efficacy and safety of combined treatment with tranilast and minocycline for rosacea. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients.
- Conditions
- Rosacea
- Being tested
- minocycline, tranilast
- Keywords
- rosacea, mast cell stabilizers, tranilast, minocycline, treatment, clinical research
- Medical subject headings
- Rosacea, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minocyclineDrug
The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.
tranilastDrug
The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| minocycline treatment group | Experimental | The patient was treated with oral minocycline capsules, 50mg each time, once a day, for 12 weeks. Receives: Drug: minocycline |
| tranilast treatment group | Experimental | The patient was treated with oral tranilast capsules, 0.1g each time, three times a day, for 12 weeks. Receives: Drug: tranilast |
| tranilast combined with minocycline treatment group | Experimental | The patient was treated with oral tranilast capsules, 0.1g each time, three times a day; oral minocycline capsules, 50mg each time, once a day, for 12 weeks. Receives: Drug: minocycline; Drug: tranilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
lesion counts
The counts of skin lesions, including papules, pustules, and papulopustules, was used to evaluate the changes of facial inflammatory skin lesions before and after treatment.
Measured: From enrollment to week 12
Clinician's Erythema Assessment score
The name of the scale is Clinician's Erythema Assessment. It was used to evaluate the change of persistent facial erythema before and after treatment. The score on the Clinician's Erythema Assessment scale ranges from 0 to 9, with higher scores indicating more severe persistent erythema on the patient's face.
Measured: From enrollment to week 12
Global Flushing Severity Scale score
The name of the scale is Global Flushing Severity Scale. It was used to evaluate the change of facial flushing symptoms before and after treatment. The score on the Global Flushing Severity Scale ranges from 0 to 10, with higher scores indicating more severe symptoms of facial flushing.
Measured: From enrollment to week 12
Global Acne Grading System score
The name of the scale is Global Acne Grading System. It was used to evaluate the changes of facial inflammatory skin lesions before and after treatment. The Global Acne Grading System score ranges from 0 to 32, with higher scores indicating more inflammatory lesions on the patient's face.
Measured: From enrollment to week 12
Secondary outcomes (5)
patient satisfaction evaluation
Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied.
Measured: week 12
melanin index
Use non-invasive skin analyzer to measure the melanin index on the patient's facial skin at each follow-up visit.
Measured: From enrollment to week 12
erythema index
Use non-invasive skin analyzer to measure the erythema index on the patient's facial skin at each follow-up visit.
Measured: From enrollment to week 12
transepidermal water loss
Use non-invasive skin analyzer to measure the transepidermal water loss on the patient's facial skin at each follow-up visit.
Measured: From enrollment to week 12
Dermatology Life Quality Index score
The name of the scale is Dermatology Life Quality Index. It was used to assess the changes in quality of life before and after treatment. The Dermatology Life Quality Index score ranges from 0 to 29, with higher scores indicating a greater impact of the disease on the patient's quality of life.
Measured: week 0 and12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start16 Oct 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
- Investigators
- Weihui Zeng, Study chair, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307288
- Sponsor's protocol ID
- 20240301-2
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marchitto MC, Chien AL. Mast Cell Stabilizers in the Treatment of Rosacea: A Review of Existing and Emerging Therapies. Dermatol Ther (Heidelb). 2021 Oct;11(5):1541-1549. doi: 10.1007/s13555-021-00597-7. Epub 2021 Sep 2.
PubMed 34476755Aroni K, Tsagroni E, Kavantzas N, Patsouris E, Ioannidis E. A study of the pathogenesis of rosacea: how angiogenesis and mast cells may participate in a complex multifactorial process. Arch Dermatol Res. 2008 Mar;300(3):125-31. doi: 10.1007/s00403-007-0816-z. Epub 2007 Dec 11.
PubMed 18071725Wozniak E, Owczarczyk-Saczonek A, Lange M, Czarny J, Wygonowska E, Placek W, Nedoszytko B. The Role of Mast Cells in the Induction and Maintenance of Inflammation in Selected Skin Diseases. Int J Mol Sci. 2023 Apr 10;24(8):7021. doi: 10.3390/ijms24087021.
PubMed 37108184Del Rosso JQ, Webster G, Weiss JS, Bhatia ND, Gold LS, Kircik L. Nonantibiotic Properties of Tetracyclines in Rosacea and Their Clinical Implications. J Clin Aesthet Dermatol. 2021 Aug;14(8):14-21. Epub 2021 Aug 1.
PubMed 34840653Schaller M, Almeida LMC, Bewley A, Cribier B, Del Rosso J, Dlova NC, Gallo RL, Granstein RD, Kautz G, Mannis MJ, Micali G, Oon HH, Rajagopalan M, Steinhoff M, Tanghetti E, Thiboutot D, Troielli P, Webster G, Zierhut M, van Zuuren EJ, Tan J. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020 May;182(5):1269-1276. doi: 10.1111/bjd.18420. Epub 2019 Oct 16.
PubMed 31392722Tan J, Almeida LM, Bewley A, Cribier B, Dlova NC, Gallo R, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren EJ, Schaller M. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):431-438. doi: 10.1111/bjd.15122. Epub 2017 Jan 23.
PubMed 27718519Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.
PubMed 27861741
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea
- ClinicalTrials.gov ID
- NCT06307288
- Acronym / sponsor ID
- 20240301-2
- Conditions
- Rosacea
- Keywords
- rosacea, mast cell stabilizers, tranilast, minocycline, treatment, clinical research
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients.
Detailed description
Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. In the skin, mast cells are located in the dermis near nerve endings and blood vessels, playing a crucial role in inflammatory responses. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. However, there is currently a lack of clinical studies evaluating the efficacy and safety of combined treatment with tranilast and minocycline for rosacea. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| minocycline treatment group | Experimental | Drug: minocyclineThe patient was treated with oral minocycline capsules, 50mg each time, once a day, for 12 weeks. |
| tranilast treatment group | Experimental | Drug: tranilastThe patient was treated with oral tranilast capsules, 0.1g each time, three times a day, for 12 weeks. |
| tranilast combined with minocycline treatment group | Experimental | Drug: minocycline, Drug: tranilastThe patient was treated with oral tranilast capsules, 0.1g each time, three times a day; oral minocycline capsules, 50mg each time, once a day, for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and nonpregnant females, aged 18-60 years old;
- Diagnosed with erythematotelangiectatic or papulopustular rosacea, with an investigator' s global assessment of 3-5;
- Patients with good cognitive function and normal mental status;
- Patients with good communication skills;
- Voluntary participation in the study and signing of informed consent form.
Key exclusion criteria (5 listed)
- Allergy to any component of tranilast capsules;
- Allergy to any component of minocycline capsules;
- History of systemic medication for rosacea treatment within the past month;
- Pregnancy or lactation;
- Presence of severe primary diseases in addition to rosacea, such as cardiovascular system, cerebrovascular system, digestive system, urinary system, hematopoietic system diseases, or systemic failure.
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 |
|---|---|---|
| minocyclineThe patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks. | Drug | minocycline treatment group, tranilast combined with minocycline treatment group |
| tranilastThe patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks. | Drug | tranilast combined with minocycline treatment group, tranilast treatment group |
Primary outcome
lesion counts
Time frame: From enrollment to week 12
The counts of skin lesions, including papules, pustules, and papulopustules, was used to evaluate the changes of facial inflammatory skin lesions before and after treatment.
Clinician's Erythema Assessment score
Time frame: From enrollment to week 12
The name of the scale is Clinician's Erythema Assessment. It was used to evaluate the change of persistent facial erythema before and after treatment. The score on the Clinician's Erythema Assessment scale ranges from 0 to 9, with higher scores indicating more severe persistent erythema on the patient's face.
Global Flushing Severity Scale score
Time frame: From enrollment to week 12
The name of the scale is Global Flushing Severity Scale. It was used to evaluate the change of facial flushing symptoms before and after treatment. The score on the Global Flushing Severity Scale ranges from 0 to 10, with higher scores indicating more severe symptoms of facial flushing.
Global Acne Grading System score
Time frame: From enrollment to week 12
The name of the scale is Global Acne Grading System. It was used to evaluate the changes of facial inflammatory skin lesions before and after treatment. The Global Acne Grading System score ranges from 0 to 32, with higher scores indicating more inflammatory lesions on the patient's face.
5 secondary outcomes
patient satisfaction evaluation
Time frame: week 12
melanin index
Time frame: From enrollment to week 12
erythema index
Time frame: From enrollment to week 12
transepidermal water loss
Time frame: From enrollment to week 12
Dermatology Life Quality Index score
Time frame: week 0 and12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 34476755Marchitto MC, Chien AL. Mast Cell Stabilizers in the Treatment of Rosacea: A Review of Existing and Emerging Therapies. Dermatol Ther (Heidelb). 2021 Oct;11(5):1541-1549. doi: 10.1007/s13555-021-00597-7. Epub 2021 Sep 2.
- Results publication: PubMed 18071725Aroni K, Tsagroni E, Kavantzas N, Patsouris E, Ioannidis E. A study of the pathogenesis of rosacea: how angiogenesis and mast cells may participate in a complex multifactorial process. Arch Dermatol Res. 2008 Mar;300(3):125-31. doi: 10.1007/s00403-007-0816-z. Epub 2007 Dec 11.
- Results publication: PubMed 37108184Wozniak E, Owczarczyk-Saczonek A, Lange M, Czarny J, Wygonowska E, Placek W, Nedoszytko B. The Role of Mast Cells in the Induction and Maintenance of Inflammation in Selected Skin Diseases. Int J Mol Sci. 2023 Apr 10;24(8):7021. doi: 10.3390/ijms24087021.
- Results publication: PubMed 34840653Del Rosso JQ, Webster G, Weiss JS, Bhatia ND, Gold LS, Kircik L. Nonantibiotic Properties of Tetracyclines in Rosacea and Their Clinical Implications. J Clin Aesthet Dermatol. 2021 Aug;14(8):14-21. Epub 2021 Aug 1.
- Results publication: PubMed 31392722Schaller M, Almeida LMC, Bewley A, Cribier B, Del Rosso J, Dlova NC, Gallo RL, Granstein RD, Kautz G, Mannis MJ, Micali G, Oon HH, Rajagopalan M, Steinhoff M, Tanghetti E, Thiboutot D, Troielli P, Webster G, Zierhut M, van Zuuren EJ, Tan J. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020 May;182(5):1269-1276. doi: 10.1111/bjd.18420. Epub 2019 Oct 16.
- Results publication: PubMed 27718519Tan J, Almeida LM, Bewley A, Cribier B, Dlova NC, Gallo R, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren EJ, Schaller M. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):431-438. doi: 10.1111/bjd.15122. Epub 2017 Jan 23.
- Results publication: PubMed 27861741Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Weihui Zeng study chair
Second Affiliated Hospital of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing minocycline and tranilast in people with Rosacea, run by Second Affiliated Hospital of Xi'an Jiaotong University 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lesion counts (time frame: From enrollment to week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307288, which also lists 7 linked publications.
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 12 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.