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. (BR14004)

A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel (5 mg/g Brimonidine Tartrate) in Patients With Chronic Persistent Vascular Facial Erythema.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Persistent Vascular Facial Erythema
• Intervention / Treatment: Drug: brimonidine tartrate

Detailed Description

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
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22471003
      • Instituto de Dermatologia e Estética do Brasil LTDA
  • RS
    • Porto Alegre - RS, RS, Brazil, 91781200
      • Centro Brasileiro de Estudos em Dermatologia
  • SP
    • Botucatu, SP, Brazil, 18603-440
      • Clinica Drmatologica Dra. Laura Buratini Ltda.
    • Sao Paulo, SP, Brazil, 04564000
      • Hosptial do Servidor Publico Municipal
    • São Paulo, SP, Brazil, 09041-410
      • Fundacao do ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female research participants aged 18 or higher.
2. 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.
3. Clinician Erythema Assessment scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to study treatment administration.
4. Patient Self-Evaluation scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to study treatment administration.
5. 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).
6. 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).
7. Patients willing and able to fulfill the protocol requirements and duration.
8. Patients who understand and sign the Informed Consent Form at study inclusion, before any study procedure is carried out.

Exclusion Criteria:

- Any research participant that meets one or more of the following criteria is not eligible for the trial:

1. Female patients who are pregnant, breastfeeding or planning for pregnancy.
2. Current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics or alpha agonists.
3. 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.
4. 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.
5. 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).
6. 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).

7. 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.

8. Exposure to excessive ultraviolet radiation within a week before Day 1 visit.
9. 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.
10. Patients who do not wish to abstain from the use of forbidden medication or excessive exposure to ultraviolet radiation during the study period.
11. 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.
12. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mirvaso® gel; Mirvaso® gel (5 mg/g brimonidine tartrate)	Drug: brimonidine tartrate; Mirvaso® gel (5 mg/g brimonidine tartrate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; 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 Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Galderma Brasil Ltda.
• Collaborators: Eurotrials Brasil Consultores Cientificos Ltda

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2016
• Primary Completion (Actual): February 8, 2017
• Study Completion (Actual): February 8, 2017

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Skin Manifestations; Erythema; Facies; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: BR.14.004