Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02637232
• Collaborator: Chiltern International Inc. (Industry)
• Enrollment: 301
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 43

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Other: Mirvaso® / Onreltea TM

Study Design

• Study Type: Observational
• Actual Enrollment: 301 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Mirvaso® Utilisation and Patient Satisfaction Evaluation
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Mirvaso® / Onreltea TM	Other: Mirvaso® / Onreltea TM

Outcome Measures

Primary Outcome Measures

1. Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question [Week 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator site 1	Hamilton		Canada

Sponsors and Collaborators

• Galderma R&D
• Chiltern International Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02637232
• Other Study ID Numbers: RD.03.SPR.104160
• First Posted: Dec 22, 2015
• Last Update Posted: May 28, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Rosacea; Brimonidine Tartrate

Study Results

Participant Flow

Arm/Group Title	Mirvaso® / Onreltea TM
Arm/Group Description	Mirvaso® / Onreltea TM
Period Title: Overall Study
STARTED	301
COMPLETED	246
NOT COMPLETED	55

Baseline Characteristics

Arm/Group Title	Mirvaso® / Onreltea TM
Arm/Group Description	Mirvaso® / Onreltea TM
Overall Participants	301
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	48.4 (14.7)
Sex: Female, Male (Count of Participants)
Female	218 72.4%
Male	83 27.6%
Duration of rosacea (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	5.5 (7.9)
Previous therapies in the last 2 years (Count of Participants)
Count of Participants [Participants]	150 49.8%
Subject previously prescribed by Mirvaso (Count of Participants)
Count of Participants [Participants]	65 21.6%
Severity of facial erythema (by physician) (Count of Participants)
Mild	68 22.6%
Moderate	179 59.5%
Severe	53 17.6%
Missing	1 0.3%
Severity of facial erythema (by subject) (Count of Participants)
Mild	58 19.3%
Moderate	169 56.1%
Severe	73 24.3%
Missing	1 0.3%
Additional signs and Symptoms (Count of Participants)
Flushing present	250 83.1%
Papules and Pustules	127 42.2%
Skin burning & stinging sensation	151 50.2%
Rhinophyma	16 5.3%
Ocular manifestation	29 9.6%
Telangiectasis	205 68.1%
Other signs and symptoms	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mirvaso® / Onreltea TM
Arm/Group Description	Mirvaso® / Onreltea TM
Measure Participants	237
Very satisfied	55 18.3%
Somewhat satisfied	86 28.6%
Neither satisfied nor dissatisfied	38 12.6%
Somewhat dissatisfied	31 10.3%
Very dissatisfied	27 9%

Adverse Events

Time Frame	From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Adverse Event Reporting Description	Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
Arm/Group Title	Mirvaso® / Onreltea TM
Arm/Group Description	Mirvaso® / Onreltea TM
All Cause Mortality
	Mirvaso® / Onreltea TM
	Affected / at Risk (%)	# Events
Total	0/259 (0%)
Serious Adverse Events
	Mirvaso® / Onreltea TM
	Affected / at Risk (%)	# Events
Total	1/259 (0.4%)
Cardiac disorders
ANGINA PECTORIS	1/259 (0.4%)	1
Vascular disorders
AORTIC ECTASIA	1/259 (0.4%)	1
STENOSIS OF ILIACA EXTERNAL	1/259 (0.4%)	1
RIVA STENOSIS	1/259 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Mirvaso® / Onreltea TM
	Affected / at Risk (%)	# Events
Total	61/259 (23.6%)
Skin and subcutaneous tissue disorders
Erythema	32/259 (12.4%)	36
Pruritus	7/259 (2.7%)	7
Rosacea	8/259 (3.1%)	8
Skin burning sensation	33/259 (12.7%)	36
Skin irritation	17/259 (6.6%)	17
Skin swelling	7/259 (2.7%)	10
Vascular disorders
Flushing	30/259 (11.6%)	30

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

This is an agreement between the PI and sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Disclosure agreement is covered by a contract.