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RosaceaPhase 4NCT02249065

Mirvaso in Use Study

A Phase 4 study testing Brimonidine in people with Rosacea, run by Galderma R&D at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to: 1. assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel 2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment 3. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rosacea
What is being tested?
Brimonidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
12 sitesUnited States
Study dates
Sep 2014to Aug 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subjects must be 18 years of age or older at time of study consent.
  • Subjects with a board certified dermatologist (BCD) clinical diagnosis of facial erythema of rosacea and eligible for treatment with Mirvaso® (brimonidine) topical gel, 0.33% per package insert.
  • Subjects with a clinician's erythema assessment (CEA) score of ~3 at Screening Visit 1.
  • Subjects with less than 3 facial inflammatory lesions of rosacea at Screening/Visit 1.
  • Subjects must be willing and able to give written informed consent including photography consent. Consent and photo consent will be obtained prior to any study related procedures
  • Females of childbearing potential with a negative urine pregnancy test (UPT) at Visit 1 (prior to test article application) or females of non-childbearing potential (deemed as post-menopausal [absence of menstrual bleeding for at least 1 year prior to enrollment], hysterectomy or bilateral oophorectomy).

Who cannot join

  • Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
  • Subjects with current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjogren's syndrome or depression.
  • Subjects with previous refractive eye surgery such as photorefractive keratectomy, laser-assisted sub-epithelial keratectomy, or laser-assisted in situ keratomileusis.
  • Current treatment with monoamine oxidase inhibitors.
  • Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha- agonists.
  • Less than 3 months (90 days) stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
Show all 17Show fewer
  • Subjects with any uncontrolled chronic or serious disease or medical condition that would normally prevent participation in a clinical study, or, in the judgment of the investigator, would put the subjects at undue risk, or might confound the study assessments (e.g., other dermatological diseases), or might interfere with the subjects' participation in the study, (e.g., planned hospitalization during the study).
  • Subjects who have received, applied, or taken treatments with drugs, cosmetics or devices known to cause facial erythema and who are deemed ineligible by the investigator.
  • Subjects with known allergies or sensitivities to any component of the study drug, including the active ingredient brimonidine tartrate label (refer to the package insert for Mirvaso® (brimonidine) topical gel, 0.33%).
  • Subjects with prior treatment with brimonidine gel, oxymetazoline or other (topical and/or systemic) alpha adrenergic agonists.
  • Subjects who are pregnant or breast-feeding or planning to become pregnant during the course of the study.
  • Subjects exposed to excessive ultraviolet (UV) radiation within I week prior to baseline and/or subject was unwilling to refrain from excessive exposure to UV radiation during the course of the study.
  • Subjects with the presence of a beard or excessive facial hair that would interfere with the study treatments or study assessments as deemed by the investigator, and refusal to remove beard or facial hair for duration of the study.
  • Subjects with non-stable dose of current (last 60 days) use of prescription rosacea medications.
  • Subjects with uncontrolled rosacea associated with inflammatory pustules and papules.
  • Study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.
  • Subjects with participation in any investigational study within 30 days of entry into this study or concomitantly with this study

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Arlington Research Center

    Arlington, Texas, 76011

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • DermDox Centers for Dermatology

    Hazleton, Pennsylvania, 18201

  • Florida Academic Dermatology Center

    Miami, Florida, 33136

  • Manhattan Dermatology and Cosmetic Surgery

    New York, New York, 10017

  • Blue Harbor Dermatology

    Newport Beach, California, 92663

  • Advanced Skin Research Center

    Omaha, Nebraska, 68144

  • Center for Dermatology and Laser Surgery

    Sacramento, California, 95819

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Redwood Dermatology Research

    Santa Rosa, California, 95403

  • Grekin Skin Institute

    Warren, Michigan, 48088

  • Research Institute of the Southeast

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)

This study is designed to:

  1. assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel
  2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment
  3. gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.
Conditions
Rosacea
Being tested
Brimonidine
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrimonidineDrug

    Also called Mirvaso Gel

Study groups in NCT02249065
Study groupRoleWhat they receive
Mirvaso GelExperimentalBrimonidine topical gel, 0.33%
Receives: Drug: Brimonidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-Treatment Clinician Erythema Assessment (CEA)

    The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.

    Measured: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)

Secondary outcomes (4)

  1. Subject Facial Redness Questionnaire

    Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)

    Measured: 14 days (Day 1 (Baseline) and Day 14/Exit)

  2. Subject Treatment Satisfaction Questionnaire

    Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)

    Measured: 14 days (Day 14/Exit)

  3. Facial Redness Visual Analog Scale (VAS)

    The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS

    Measured: 14 days (Day 1 (Baseline), Day 14/Exit)

  4. Inflammatory Lesions

    Change from baseline in facial inflammatory lesion count

    Measured: 14 days (Day 1 (Baseline) and Day 14/Exit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02249065
Sponsor's protocol ID
GLI.04.SPR.US 10305
Status last verified
Nov 2017
First submitted
23 Sep 2014
Last updated
1 Aug 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brimonidine in people with Rosacea, run by Galderma R&D at 12 sites in United States.

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 6 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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?

Yes. Results are posted in the registry (first posted 19 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pre-Treatment Clinician Erythema Assessment (CEA) (time frame: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02249065.

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 1 Aug 2022.

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