RosaceaPhase 4MOSAICNCT02616250

MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.

A Phase 4 study testing Brimonidine 0.33% gel (Br) and Ivermectin 1% cream (IVM) in people with Rosacea, run by Galderma R&D at 13 sites in 2 countries.

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

The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea. 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 0.33% gel (Br) and Ivermectin 1% cream (IVM)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 13 sitesin 2 countries
Study dates: Dec 2015to Sep 2016
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

Main Inclusion Criteria:

Male or female subjects age 18 years or older;
Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;
Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]);
Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]);
Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
Female subjects of childbearing potential must practice a highly effective method of contraception during the study;
Females subjects of non-childbearing potential;

Main Exclusion Criteria:

Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
Subjects with more than 2 nodules of rosacea on the face;
Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;

Trial locations and contacts

13 sites in 2 countries.

Country

City, postcode or hospital

13 sites in 2 countries

United States7 sites

Study site
Fort Smith, Arkansas
Study site
New York, New York
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Pflugerville, Texas
Study site
Rogers, Arkansas
Study site
Sacramento, California

Other trials in United States

Canada6 sites

Study site
Markham, Ontario
Study site
Peterborough, Ontario
Study site
Richmond Hill, Ontario
Study site
Surrey, British Columbia
Study site
Waterloo, Ontario
Study site
Windsor, Ontario

Other trials in Canada

About this study

Official title: Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea

Conditions: Rosacea
Being tested: Brimonidine 0.33% gel (Br), CD07805/47 (Br) placebo gel, Ivermectin 1% cream (IVM), CD5024 (IVM) placebo cream
Medical subject headings: Rosacea

What participants receive

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

Brimonidine 0.33% gel (Br)Drug
CD07805/47 (Br) placebo gelOther
Ivermectin 1% cream (IVM)Drug
CD5024 (IVM) placebo creamOther

Study groups in NCT02616250
Study group	Role	What they receive
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream	Experimental	Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks. Receives: Drug: Brimonidine 0.33% gel (Br); Other: CD07805/47 (Br) placebo gel; Drug: Ivermectin 1% cream (IVM)
CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream	Placebo comparator	Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. Receives: Other: CD07805/47 (Br) placebo gel; Other: CD5024 (IVM) placebo cream

What is being measured

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

Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)
Measured: week 12/Hour 3

Timeline

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

Dec 2015Sep 2016

First posted26 Nov 2015 (estimated)
Study startDec 2015
Primary completionSep 2016
Study completionSep 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.
More trials run by Galderma R&DThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02616250
Sponsor's protocol ID: RD.03.SPR.105069
Acronym: MOSAIC
Status last verified: Feb 2018
First submitted: 24 Nov 2015
Last updated: 18 Feb 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

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
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RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
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Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
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All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea
ClinicalTrials.gov ID: NCT02616250
Acronym / sponsor ID: MOSAIC / RD.03.SPR.105069
Conditions: Rosacea
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 26 Nov 2015 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream	Experimental	Drug: Brimonidine 0.33% gel (Br), Other: CD07805/47 (Br) placebo gel, Drug: Ivermectin 1% cream (IVM)Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream	Placebo comparator	Other: CD07805/47 (Br) placebo gel, Other: CD5024 (IVM) placebo creamSubjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.

Who may qualify

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

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 0.33% gel (Br)	Drug	Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream
CD07805/47 (Br) placebo gel	Other	Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream, CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream
Ivermectin 1% cream (IVM)	Drug	Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream
CD5024 (IVM) placebo cream	Other	CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream

Primary outcome

Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
Time frame: week 12/Hour 3
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)

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
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream	95	85
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream	95	86

Primary outcome: Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):

Time frame: week 12/Hour 3. Count of participants. Unit: Participants

Measure	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream n = 95	CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream n = 95
Value	53	35

Population analysed: Intent To Treat (ITT) Population

Adverse events

Time frame: All AEs occurring after subject's consent and during the study were recorded; 3 months for a given subject 10 months for the study; ie: from first subject enrolled until last visit of last subject enrolled. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream	5 of 95 (5.3%)	8 of 95 (8.4%)	0 of 95
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream	1 of 95 (1.1%)	13 of 95 (13.7%)	0 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rosacea

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
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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.

13 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brimonidine 0.33% gel (Br) and Ivermectin 1% cream (IVM) in people with Rosacea, run by Galderma R&D at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, 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. Some participants in this study may receive a placebo. 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?

Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): (time frame: week 12/Hour 3). 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 NCT02616250.

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 18 Feb 2021.