Mirvaso in Use Study

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02249065
• Collaborator: (none)
• Enrollment: 205
• Locations: 12
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 17.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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. gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Brimonidine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mirvaso Gel Brimonidine topical gel, 0.33%	Drug: Brimonidine; Other Names: Mirvaso Gel

Outcome Measures

Primary Outcome Measures

1. Pre-Treatment Clinician Erythema Assessment (CEA) [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.

Secondary Outcome Measures

1. Subject Facial Redness Questionnaire [14 days (Day 1 (Baseline) and Day 14/Exit)]

   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)

2. Subject Treatment Satisfaction Questionnaire [14 days (Day 14/Exit)]

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

3. Facial Redness Visual Analog Scale (VAS) [14 days (Day 1 (Baseline), Day 14/Exit)]

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

4. Inflammatory Lesions [14 days (Day 1 (Baseline) and Day 14/Exit)]

   Change from baseline in facial inflammatory lesion count

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subjects must be 18 years of age or older at time of study consent.

2. 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.

3. Subjects with a clinician's erythema assessment (CEA) score of ~3 at Screening Visit

5. Subjects with less than 3 facial inflammatory lesions of rosacea at Screening/Visit 1.

6. 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

7. 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).

Exclusion Criteria:

1. 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.

2. 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.

3. Subjects with previous refractive eye surgery such as photorefractive keratectomy, laser-assisted sub-epithelial keratectomy, or laser-assisted in situ keratomileusis.

4. Current treatment with monoamine oxidase inhibitors.

5. Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha- agonists.

6. Less than 3 months (90 days) stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.

7. 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).

8. 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.

9. 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%).

10. Subjects with prior treatment with brimonidine gel, oxymetazoline or other (topical and/or systemic) alpha adrenergic agonists.

11. Subjects who are pregnant or breast-feeding or planning to become pregnant during the course of the study.

12. 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.

13. 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.

14. Subjects with non-stable dose of current (last 60 days) use of prescription rosacea medications.

15. Subjects with uncontrolled rosacea associated with inflammatory pustules and papules.

16. Study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.

17. Subjects with participation in any investigational study within 30 days of entry into this study or concomitantly with this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johnson Dermatology	Fort Smith	Arkansas	United States	72916
2	Blue Harbor Dermatology	Newport Beach	California	United States	92663
3	Center for Dermatology and Laser Surgery	Sacramento	California	United States	95819
4	Redwood Dermatology Research	Santa Rosa	California	United States	95403
5	Florida Academic Dermatology Center	Miami	Florida	United States	33136
6	Research Institute of the Southeast	West Palm Beach	Florida	United States	33401
7	Grekin Skin Institute	Warren	Michigan	United States	48088
8	Advanced Skin Research Center	Omaha	Nebraska	United States	68144
9	Manhattan Dermatology and Cosmetic Surgery	New York	New York	United States	10017
10	DermDox Centers for Dermatology	Hazleton	Pennsylvania	United States	18201
11	Arlington Research Center	Arlington	Texas	United States	76011
12	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Jeffrey Sugarman, MD, Redwood Dermatology Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02249065
• Other Study ID Numbers: GLI.04.SPR.US 10305
• First Posted: Sep 25, 2014
• Last Update Posted: Aug 1, 2022
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Rosacea; Brimonidine Tartrate

Study Results

Participant Flow

Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel (topical emulsion (gel), 0.33% brimonidine, once daily)
Period Title: Overall Study
STARTED	205
Treated	181
COMPLETED	176
NOT COMPLETED	29

Baseline Characteristics

Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel
Overall Participants	181
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	143 79%
>=65 years	38 21%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	52.4
Sex: Female, Male (Count of Participants)
Female	136 75.1%
Male	45 24.9%
Region of Enrollment (Count of Participants)
United States	181 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel
Measure Participants	181
Clear Skin	0 0%
Almost Clear	0 0%
Mild Erythema	7 3.9%
Moderate Erythema	144 79.6%
Severe Erythema	30 16.6%
Missing	0 0%
Clear Skin	3 1.7%
Almost Clear	18 9.9%
Mild Erythema	39 21.5%
Moderate Erythema	84 46.4%
Severe Erythema	24 13.3%
Missing	13 7.2%
Clear Skin	4 2.2%
Almost Clear	25 13.8%
Mild Erythema	39 21.5%
Moderate Erythema	86 47.5%
Severe Erythema	27 14.9%
Missing	0 0%

2. Secondary Outcome

Title	Subject Facial Redness Questionnaire
Description	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)
Time Frame	14 days (Day 1 (Baseline) and Day 14/Exit)

Outcome Measure Data

Analysis Population Description

ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment

Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel
Measure Participants	181
Not Bothered (Mean [SD], Day 1, Baseline)	75.3 (39.4) 41.6%
Bothered (Mean [SD], Day 1, Baseline)	104.7 (40.3) 57.8%
Missing (Day 1, Baseline)	1 (0) 0.6%
Not Bothered (Mean [SD], Day 14)	112.6 (28.9) 62.2%
Bothered (Mean [SD], Day 14)	67.3 (26.2) 37.2%
Missing (Day 14)	1.1 (.3) 0.6%

3. Secondary Outcome

Title	Subject Treatment Satisfaction Questionnaire
Description	Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
Time Frame	14 days (Day 14/Exit)

Outcome Measure Data

Analysis Population Description

ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment

Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel
Measure Participants	181
Satisfied Participants (Mean [SD])	127.3 (22.2) 70.3%
Dissatisfied Participants (Mean [SD])	52.7 (22.2) 29.1%
Missing	1.0 (0.0) 0.6%

4. Secondary Outcome

Title	Facial Redness Visual Analog Scale (VAS)
Description	The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS
Time Frame	14 days (Day 1 (Baseline), Day 14/Exit)

Outcome Measure Data

Analysis Population Description

ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment

Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel
Measure Participants	181
None	1 0.6%
Very Mild	31 17.1%
Mild	57 31.5%
Moderate	48 26.5%
Severe	38 21%
Very Severe	6 3.3%
None	1 0.6%
Very Mild	63 34.8%
Mild	45 24.9%
Moderate	44 24.3%
Severe	22 12.2%
Very Severe	6 3.3%

5. Secondary Outcome

Title	Inflammatory Lesions
Description	Change from baseline in facial inflammatory lesion count
Time Frame	14 days (Day 1 (Baseline) and Day 14/Exit)

Outcome Measure Data

Analysis Population Description

ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment

Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel
Measure Participants	181
Day 1: Lesions	.6 (1.2)
Day 14: Lesions	1.5 (4.4)
Day 14: Change From Baseline	1 (3.9)

Adverse Events

Time Frame	29 Days
Adverse Event Reporting Description	Adverse events were recorded for at least 14 days prior to the first treatment application.
Arm/Group Title	Mirvaso Gel
Arm/Group Description	Brimonidine Gel
All Cause Mortality
	Mirvaso Gel
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Mirvaso Gel
	Affected / at Risk (%)	# Events
Total	3/181 (1.7%)
Cardiac disorders
myocardial infarction	1/181 (0.6%)
Pericarditis	1/181 (0.6%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/181 (0.6%)
Other (Not Including Serious) Adverse Events
	Mirvaso Gel
	Affected / at Risk (%)	# Events
Total	68/181 (37.6%)
General disorders
condition aggravated	33/181 (18.2%)
feeling hot	4/181 (2.2%)
Infections and infestations
nasopharyngitis	6/181 (3.3%)
Skin and subcutaneous tissue disorders
rosacea	21/181 (11.6%)
Erythema	7/181 (3.9%)

Limitations/Caveats

Open label, single arm, short duration.

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.