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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Mirvaso® gel (5 mg/g brimonidine tartrate)
Instituto de Dermatologia e Estética do Brasil Ltda
Rio de Janeiro, Rio de Janeiro, Brazil
Centro Brasileiro de Estudos em Dermatologia
Porto Alegre - RS, Rio Grande do Sul, Brazil
Clinica Drmatologica Dra. Laura Buratini Ltda.
Botucatu, São Paulo, Brazil
Hosptial do Servidor Publico Municipal
São Paulo, São Paulo, Brazil
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. * 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; No Mirvaso® gel will be applied after the visit on Day 29; • Unscheduled visits may be performed during the trial for any safety reason.
Time frame: 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. * 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; No Mirvaso® gel will be applied after the visit on Day 29; * Unscheduled visits may be performed during the trial for any safety reason.
Time frame: 1 year
Evaluate the efficacy of Mirvaso by the Patient Self Evaluation - PSE
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Fundação do ABC
São Paulo, São Paulo, Brazil
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
Time frame: 1 year
Evaluate the efficacy of Mirvaso by the clinician erythema assessment - CEA
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.
Time frame: 1 year
Incidence of AEs. Evaluate the safety of Mirvaso
To evaluate the safety of Mirvaso up to 6 weeks after beginning the treatment
Time frame: 1 year
Study Participant Satisfaction Questionnaire
Research participants will fill the Study Participant Satisfaction Questionnaire at Hour 3 on Day 29 with 7 questions.
Time frame: 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.
Time frame: 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.
Time frame: 1 year