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| Name | Class |
|---|---|
| Eurotrials Brasil Consultores Cientificos Ltda | INDUSTRY |
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This study evaluates the efficacy of Mirvaso® in the treatment of chronic persistent vascular facial erythema, after 4 weeks of treatment, by the Clinician erythema assessment.
This is a multicenter, open-label trial in research participants with chronic persistent vascular facial erythema. All eligible research participants will receive Mirvaso® gel once daily for 4 weeks, and then will be followed-up for another 2 weeks.
The study will include 4 clinical visits: before Day 1, on Day 1, Day 29 and Week 6.
Within 5 days before Day 1, the research participant will have a screening visit for confirmation of eligibility.
On Day 1 and on Day 29, the research participant will have Mirvaso® gel applied, at the research site, and the evaluation will be conducted before application and 3 hours after application; During Days 2-28, research participants will have Mirvaso® gel applied once daily, at home; On Week 6, the research participants will go back to the research site for evaluation. No Mirvaso® gel will be applied after the visit on Day 29; Unscheduled visits may be performed during the trial for any safety reason.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirvaso® gel | Other | Mirvaso® gel (5 mg/g brimonidine tartrate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brimonidine tartrate | Drug | Mirvaso® gel (5 mg/g brimonidine tartrate) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoints: Percentage of research participants with at least 1 degree of improvement from baseline in PSE on each moment of post-baseline evaluation | • Facial Erythema based on the Patient self-Evaluation (PSE) evaluated by the research participant on Day 1 (Hour 0 and Hour 3), Day 29 (Hour 0 and Hour 3). All eligible research participants will receive Mirvaso® gel once daily for 4 weeks. The study will include 4 clinical visits: before Day 1, on Day 1, Day 29 and Week 6.
No Mirvaso® gel will be applied after the visit on Day 29; • Unscheduled visits may be performed during the trial for any safety reason. | 1 year |
| Percentage of research participants with at least 1 degree of improvement from baseline in CEA on each moment of post-baseline evaluation. | • Facial Erythema based on the Clinician erythema assessment (CEA) evaluated by the investigator on Day 1 (Hour 0 and Hour 3), Day 29 (Hour 0 and Hour 3) . Clinician Erythema Assessment scores: 2 (mild), 3 (moderate), or 4 (severe) . All eligible research participants will receive Mirvaso® gel once daily for 4 weeks. The study will include 4 clinical visits: before Day 1, on Day 1, Day 29 and Week 6.
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of Mirvaso by the Patient Self Evaluation - PSE | To evaluate the efficacy of Mirvaso in the treatment of chronic persistent vascular facial erythema, after 4 and 6 weeks of treatment, by the patient self evaluation | 1 year |
| Evaluate the efficacy of Mirvaso by the clinician erythema assessment - CEA |
| Measure | Description | Time Frame |
|---|---|---|
| Instrumental Evaluation by Mexameter® | Evaluation by Mexameter®, including Day 1 (Hour 0 and Hour 3), Day 29 (Hour 0 and Hour 3) and Week 6. The equipment measures the main components of skin color, melanin and hemoglobin (erythema). This evaluation will only be performed in research sites where the necessary equipment is available. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
- Any research participant that meets one or more of the following criteria is not eligible for the trial:
Female patients who are pregnant, breastfeeding or planning for pregnancy.
Current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics or alpha agonists.
Patients who started or changed their doses of tricyclic antidepressants, cardiac glycosides, beta-blockers or other anti-hypertensive agents, in the 3 months prior to study entry.
Current diagnosis of Raynaud syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, coronary or cerebral insufficiency, hepatic or renal failure, sclerodermia, Sjögren syndrome, or depression.
Any chronic or severe uncontrolled disease or medical chronic which may interfere with the interpretation of the study results, or may present a significant healthcare risk to the patient, if he/she participates in the study in accordance with the investigator judgment. (e.g. endocrine tumors, chromocytomas, systemic diseases that cause vascular erythema).
Known or suspected allergies or hypersensitivities to any of the components of the study treatments, including the active substance of brimonidine tartrate (see summary of product characteristics).
Patients who received, applied or ingested the following treatments in accordance with the time period specified before Day 1:
Any dermatological/surgical facial procedure - 4 weeks. Immunomodulators (e.g. Methotrexate, Cyclosporin) - 4 weeks. Mirvaso® - 4 weeks.
Isotretinoin - 6 months. Immunomodulators - 90 days. Phototherapy - 4 weeks.
Exposure to excessive ultraviolet radiation within a week before Day 1 visit.
Presence of beard or excessive facial hair at Day 1, which interferes with the study treatment or study assessments and refusal to remove it during the study period.
Patients who do not wish to abstain from the use of forbidden medication or excessive exposure to ultraviolet radiation during the study period.
Vulnerable research participants (as deprived of freedom), in accordance with Section 1.61 of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH for Good Clinical Practices.
Current participation in any other clinical study with a drug or device OR participation within 30 days prior to Day 1 OR in an exclusion period of a previous clinical study (when possible).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Dermatologia e Estética do Brasil Ltda | Rio de Janeiro | Rio de Janeiro | 22471003 | Brazil | ||
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To evaluate the efficacy of Mirvaso in the treatment of chronic persistent vascular facial erythema, after 6 weeks of treatment, by the clinician erythema assessment. |
| 1 year |
| Incidence of AEs. Evaluate the safety of Mirvaso | To evaluate the safety of Mirvaso up to 6 weeks after beginning the treatment | 1 year |
| Study Participant Satisfaction Questionnaire | Research participants will fill the Study Participant Satisfaction Questionnaire at Hour 3 on Day 29 with 7 questions. | 1 year |
| To evaluate the impact in the quality of life after 4 weeks of treatment with Mirvaso | Variation in the overall score in DLQI from baseline visit to each moment of post-baseline evaluation Dermatology life quality Index (DLQI) Questionnaire on Hour 0 on Day 1 and on Hour 3 on Day 29. 10 questions to measure how much the skin problem affected the quality life. | 1 year |
| Variation in the overall score in FRQ from baseline visit to each moment of post-baseline evaluation | Variation in the overall score in FRQ from baseline visit to each moment of post-baseline evaluation Facial Redness Questionnaire (FRQ) on Hour 0 on Day 1 and on Hour 3 on Day 29. 12 questions to evaluate how much facial erythema (redness) is affecting life at the moment of answer. | 1 year |
| Centro Brasileiro de Estudos em Dermatologia |
| Porto Alegre - RS |
| Rio Grande do Sul |
| 91781200 |
| Brazil |
| Clinica Drmatologica Dra. Laura Buratini Ltda. | Botucatu | São Paulo | 18603-440 | Brazil |
| Hosptial do Servidor Publico Municipal | São Paulo | São Paulo | 04564000 | Brazil |
| Fundação do ABC | São Paulo | São Paulo | 09041-410 | Brazil |
| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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