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Trial record 8 of 152 for:    Brimonidine

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)

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ClinicalTrials.gov Identifier: NCT02856919
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Eurotrials Brasil Consultores Cientificos Ltda
Information provided by (Responsible Party):
Galderma Brasil Ltda.

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.

Condition or disease Intervention/treatment Phase
Chronic Persistent Vascular Facial Erythema Drug: brimonidine tartrate Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 13, 2016
Actual Primary Completion Date : February 8, 2017
Actual Study Completion Date : February 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Mirvaso® gel
Mirvaso® gel (5 mg/g brimonidine tartrate)
Drug: brimonidine tartrate
Mirvaso® gel (5 mg/g brimonidine tartrate)




Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. Evaluate the efficacy of Mirvaso by the Patient Self Evaluation - PSE [ Time Frame: 1 year ]
    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

  2. Evaluate the efficacy of Mirvaso by the clinician erythema assessment - CEA [ Time Frame: 1 year ]
    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.

  3. Incidence of AEs. Evaluate the safety of Mirvaso [ Time Frame: 1 year ]
    To evaluate the safety of Mirvaso up to 6 weeks after beginning the treatment

  4. Study Participant Satisfaction Questionnaire [ Time Frame: 1 year ]
    Research participants will fill the Study Participant Satisfaction Questionnaire at Hour 3 on Day 29 with 7 questions.

  5. 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 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.

  6. Variation in the overall score in FRQ from baseline visit to each moment of post-baseline evaluation [ Time Frame: 1 year ]
    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.


Other Outcome Measures:
  1. Instrumental Evaluation by Mexameter® [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856919


Locations
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Brazil
Instituto de Dermatologia e Estética do Brasil Ltda
Rio de Janeiro, RJ, Brazil, 22471003
Centro Brasileiro de Estudos em Dermatologia
Porto Alegre - RS, RS, Brazil, 91781200
Clinica Drmatologica Dra. Laura Buratini Ltda.
Botucatu, SP, Brazil, 18603-440
Hosptial do Servidor Publico Municipal
Sao Paulo, SP, Brazil, 04564000
Fundação do ABC
São Paulo, SP, Brazil, 09041-410
Sponsors and Collaborators
Galderma Brasil Ltda.
Eurotrials Brasil Consultores Cientificos Ltda

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Responsible Party: Galderma Brasil Ltda.
ClinicalTrials.gov Identifier: NCT02856919     History of Changes
Other Study ID Numbers: BR.14.004
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
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Brimonidine Tartrate
Facies
Erythema
Disease Attributes
Pathologic Processes
Skin Diseases
Skin Manifestations
Signs and Symptoms
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs