Chronic Persistent Vascular Facial ErythemaPhase 4BR14004NCT02856919
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.
A Phase 4 study testing brimonidine tartrate in people with Chronic Persistent Vascular Facial Erythema, run by Galderma Brasil Ltda. at 5 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Persistent Vascular Facial Erythema
- What is being tested?
- brimonidine tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 5 sitesBrazil
- Study dates
- 13 Jun 2016to 8 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients who understand and sign the Informed Consent Form at study inclusion, before any study procedure is carried out.
Who cannot join
- 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).
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- 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.
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Clinica Drmatologica Dra. Laura Buratini Ltda.
Botucatu, São Paulo, 18603-440
Centro Brasileiro de Estudos em Dermatologia
Porto Alegre - RS, Rio Grande do Sul, 91781200
Instituto de Dermatologia e Estética do Brasil Ltda
Rio de Janeiro, Rio de Janeiro, 22471003
Hosptial do Servidor Publico Municipal
São Paulo, São Paulo, 04564000
Fundação do ABC
São Paulo, São Paulo, 09041-410
About this study
Official title: 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.
Read the 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.
- Being tested
- brimonidine tartrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brimonidine tartrateDrug
Mirvaso® gel (5 mg/g brimonidine tartrate)
| Study group | Role | What they receive |
|---|---|---|
| Mirvaso® gel | Other | Mirvaso® gel (5 mg/g brimonidine tartrate) Receives: Drug: brimonidine tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (6)
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
Measured: 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.
Measured: 1 year
Incidence of AEs. Evaluate the safety of Mirvaso
To evaluate the safety of Mirvaso up to 6 weeks after beginning the treatment
Measured: 1 year
Study Participant Satisfaction Questionnaire
Research participants will fill the Study Participant Satisfaction Questionnaire at Hour 3 on Day 29 with 7 questions.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start13 Jun 2016
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Persistent Vascular Facial ErythemaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma Brasil Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856919
- Sponsor's protocol ID
- BR.14.004
- Acronym
- BR14004
- Status last verified
- Aug 2016
- First submitted
- 19 Jul 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02856919
- Acronym / sponsor ID
- BR14004 / BR.14.004
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Galderma Brasil Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirvaso® gel | Other | Drug: brimonidine tartrateMirvaso® gel (5 mg/g brimonidine tartrate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| brimonidine tartrateMirvaso® gel (5 mg/g brimonidine tartrate) | Drug | Mirvaso® gel |
Primary outcome
Efficacy endpoints: Percentage of research participants with at least 1 degree of improvement from baseline in PSE on each moment of post-baseline evaluation
Time frame: 1 year
• 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.
Percentage of research participants with at least 1 degree of improvement from baseline in CEA on each moment of post-baseline evaluation.
Time frame: 1 year
• 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.
6 secondary outcomes
Evaluate the efficacy of Mirvaso by the Patient Self Evaluation - PSE
Time frame: 1 year
Evaluate the efficacy of Mirvaso by the clinician erythema assessment - CEA
Time frame: 1 year
Incidence of AEs. Evaluate the safety of Mirvaso
Time frame: 1 year
Study Participant Satisfaction Questionnaire
Time frame: 1 year
To evaluate the impact in the quality of life after 4 weeks of treatment with Mirvaso
Time frame: 1 year
Variation in the overall score in FRQ from baseline visit to each moment of post-baseline evaluation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing brimonidine tartrate in people with Chronic Persistent Vascular Facial Erythema, run by Galderma Brasil Ltda. at 5 sites in Brazil.
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 8 inclusion and 17 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: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy endpoints: Percentage of research participants with at least 1 degree of improvement from baseline in PSE on each moment of post-baseline evaluation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2017; AzTrials last refreshed its copy on 31 Oct 2026.