A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel in Patients With Chronic Persistent Vascular Facial Erythema.

NCT02856919 | Completed Phase 4

• 1 other identifier: BR.14.004
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Chronic Persistent Vascular Facial Erythema

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 year

Secondary Outcomes (6)

• Evaluate the efficacy of Mirvaso by the Patient Self Evaluation - PSE

  1 year

• Evaluate the efficacy of Mirvaso by the clinician erythema assessment - CEA

  1 year

• Incidence of AEs. Evaluate the safety of Mirvaso

  1 year

• Study Participant Satisfaction Questionnaire

  1 year

• To evaluate the impact in the quality of life after 4 weeks of treatment with Mirvaso

  1 year

Other Outcomes (1)

• Instrumental Evaluation by Mexameter®

  1 year

Study Arms (1)

Mirvaso® gel

OTHER

Mirvaso® gel (5 mg/g brimonidine tartrate)

Drug: brimonidine tartrate

Interventions

brimonidine tartrate DRUG

Mirvaso® gel (5 mg/g brimonidine tartrate)

Mirvaso® gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female research participants aged 18 or higher.
• Patients with chronic persistent facial erythema (at least 1 month before baseline \[Day 1 hour 0\]) of rosacea (with no restrictions to subtypes of rosacea), or originated from other dermatological condition, including, but not limited to seborrhoeic dermatitis, ulerythema ophryogenes, keratosis pillaris, microneedling, fractional radiofrequency, post-peeling treatments (medium depth and deep) or post-laser (ablative laser). Diagnosis is based on the investigator clinical judgement.
• Clinician Erythema Assessment scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to study treatment administration.
• Patient Self-Evaluation scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to study treatment administration.
• Female patients with childbearing potential and negative pregnancy test at baseline. These patients should use a highly efficient contraceptive method during the study: combined oral contraceptives (estrogen and progesterone) or implanted contraceptives, or injectable contraceptives (with a stable dose for at least 1 month before study enrolment), bilateral tube ligation, hormonal intrauterine device (inserted at least 1 month before study entry), strict abstinence (at least 1 month prior to study entry and agreement in continuing throughout the study), or vasectomized partner (at least 3 months prior to study entry).
• Female patients without childbearing potential (e.g., before menstruating, post-menopausal \[absence of menstrual bleeding for 1 year prior to study entry\], hysterectomy, or bilateral oophorectomy, less than one year after menopause).
• Patients willing and able to fulfill the protocol requirements and duration.

You may not qualify if:

• \- 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:
• Topic facial treatments or procedures:
• Any dermatological/surgical facial procedure - 4 weeks. Immunomodulators (e.g. Methotrexate, Cyclosporin) - 4 weeks. Mirvaso® - 4 weeks.
• Systemic treatments:
• 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.

Sponsors & Collaborators

• Galderma Brasil Ltda.: lead
• Eurotrials Brasil Consultores Cientificos Ltda: collaborator

Study Sites (5)

Instituto de Dermatologia e Estética do Brasil Ltda

Rio de Janeiro, Rio de Janeiro, 22471003, Brazil

Location

Centro Brasileiro de Estudos em Dermatologia

Porto Alegre - RS, Rio Grande do Sul, 91781200, Brazil

Location

Clinica Drmatologica Dra. Laura Buratini Ltda.

Botucatu, São Paulo, 18603-440, Brazil

Location

Hosptial do Servidor Publico Municipal

São Paulo, São Paulo, 04564000, Brazil

Location

Fundação do ABC

São Paulo, São Paulo, 09041-410, Brazil

Location

MeSH Terms

Interventions

Brimonidine Tartrate

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 5, 2016
• Study Start: June 13, 2016
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: April 6, 2017

Record last verified: 2016-08

Locations

BR (5)