RosaceaMUSENCT02637232

Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)

An observational study of Rosacea, run by Galderma R&D at 1 site in Canada.

Completed

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

Trial summary

The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rosacea
What is being tested?: Mirvaso® / Onreltea TM
How many people: 301 participants
Where: 1 siteCanada
Study dates: Oct 2015to May 2016
Phase: Observational
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

Study population: patient with persistent facial erythema of rosacea

Who may be able to join

Patients to whom the physician has already decided to prescribe Mirvaso® /OnrelteaTM according to package insert

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Investigator site 1
Hamilton

Other trials in Canada

About this study

Official title: Mirvaso® Utilisation and Patient Satisfaction Evaluation

The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed.

Conditions: Rosacea
Being tested: Mirvaso® / Onreltea TM
Medical subject headings: Rosacea

What participants receive

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

Mirvaso® / Onreltea TMOther

Study groups in NCT02637232
Study group	Role	What they receive
Mirvaso® / Onreltea TM		Not described Receives: Other: Mirvaso® / Onreltea TM

What is being measured

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

Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Measured: Week 4

Timeline

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

Oct 2015May 2016

First posted22 Dec 2015 (estimated)
Study startOct 2015
Primary completionMay 2016
Study completionMay 2016

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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02637232
Sponsor's protocol ID: RD.03.SPR.104160
Acronym: MUSE
Status last verified: May 2021
First submitted: 16 Dec 2015
Last updated: 28 May 2021
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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mirvaso® Utilisation and Patient Satisfaction Evaluation
ClinicalTrials.gov ID: NCT02637232
Acronym / sponsor ID: MUSE / RD.03.SPR.104160
Conditions: Rosacea
Study type: Observational
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Collaborators: Chiltern International Inc.
Study start: Oct 2015
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 22 Dec 2015 (estimated)
Results: Posted 28 May 2021

Clinical summary

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

The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Mirvaso® / Onreltea TM	–	Other: Mirvaso® / Onreltea TM

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patient with persistent facial erythema of rosacea

Key inclusion criteria (1 listed)

Patients to whom the physician has already decided to prescribe Mirvaso® /OnrelteaTM according to package insert

Key exclusion criteria (0 listed)

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
Mirvaso® / Onreltea TM	Other	Mirvaso® / Onreltea TM

Primary outcome

Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Time frame: Week 4

Results and safety

Results posted to the registry on 28 May 2021, 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® / Onreltea TM	301	246

Primary outcome: Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question

Time frame: Week 4. Count of participants. Unit: Participants

Measure	Mirvaso® / Onreltea TM n = 237
Very satisfied	55
Somewhat satisfied	86
Neither satisfied nor dissatisfied	38
Somewhat dissatisfied	31
Very dissatisfied	27

Population analysed: Analysis was performed on total population. Here, "Overall Number of Participants Analyzed" = participants with available data for this outcome measure.

Adverse events

Time frame: From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirvaso® / Onreltea TM	1 of 259 (0.4%)	61 of 259 (23.6%)	0 of 259

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rosacea, run by Galderma R&D at 1 site in Canada.

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 1 inclusion and 0 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2021). 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?

Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question (time frame: Week 4). 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 NCT02637232.

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 28 May 2021.