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.

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.

City, postcode or hospital

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:

assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel
further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment
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 group	Role	What they receive
Mirvaso Gel	Experimental	Brimonidine topical gel, 0.33% Receives: Drug: Brimonidine

What is being measured

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

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)

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)
Subject Treatment Satisfaction Questionnaire
Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
Measured: 14 days (Day 14/Exit)
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)
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.

Sep 2014Aug 2015

First posted25 Sep 2014 (estimated)
Study startSep 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RosaceaStudies 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: 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
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
ClinicalTrials.gov ID: NCT02249065
Acronym / sponsor ID: GLI.04.SPR.US 10305
Conditions: Rosacea
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 25 Sep 2014 (estimated)
Results: Posted 19 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to:

assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel
further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment
gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.

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	Experimental	Drug: BrimonidineBrimonidine topical gel, 0.33%

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

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.

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
BrimonidineAlso: Mirvaso Gel	Drug	Mirvaso Gel

Primary outcome

Pre-Treatment Clinician Erythema Assessment (CEA)
Time frame: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
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.

4 secondary outcomes

Subject Facial Redness Questionnaire
Time frame: 14 days (Day 1 (Baseline) and Day 14/Exit)
Subject Treatment Satisfaction Questionnaire
Time frame: 14 days (Day 14/Exit)
Facial Redness Visual Analog Scale (VAS)
Time frame: 14 days (Day 1 (Baseline), Day 14/Exit)
Inflammatory Lesions
Time frame: 14 days (Day 1 (Baseline) and Day 14/Exit)

Results and safety

Results posted to the registry on 19 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirvaso Gel	205	176

Primary outcome: Pre-Treatment Clinician Erythema Assessment (CEA)

Time frame: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit). Count of participants. Unit: Participants

Measure	Mirvaso Gel n = 181
Day 1 (Baseline): Clear Skin	0
Day 1 (Baseline): Almost Clear	0
Day 1 (Baseline): Mild Erythema	7
Day 1 (Baseline): Moderate Erythema	144
Day 1 (Baseline): Severe Erythema	30
Day 1 (Baseline): Missing	0
Day 7: Clear Skin	3
Day 7: Almost Clear	18

Population analysed: Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 29 Days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirvaso Gel	3 of 181 (1.7%)	68 of 181 (37.6%)	Not reported

Limitations and caveats (from the sponsor): Open label, single arm, short duration.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rosacea

RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
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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.

Jeffrey Sugarman, MD principal investigator

Redwood Dermatology Center

12 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 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.