Mirvaso in Use Study

Rosacea Clinical Trial

Official title:

MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249065
• Other study ID #: GLI.04.SPR.US 10305
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2017
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 1.

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

5. 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

6. 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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Brimonidine

Locations

Country	Name	City	State
United States	Arlington Research Center	Arlington	Texas
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	DermDox Centers for Dermatology	Hazleton	Pennsylvania
United States	Florida Academic Dermatology Center	Miami	Florida
United States	Manhattan Dermatology and Cosmetic Surgery	New York	New York
United States	Blue Harbor Dermatology	Newport Beach	California
United States	Advanced Skin Research Center	Omaha	Nebraska
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Redwood Dermatology Research	Santa Rosa	California
United States	Grekin Skin Institute	Warren	Michigan
United States	Research Institute of the Southeast	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
Secondary	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)	14 days (Day 1 (Baseline) and Day 14/Exit)
Secondary	Subject Treatment Satisfaction Questionnaire	Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)	14 days (Day 14/Exit)
Secondary	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	14 days (Day 1 (Baseline), Day 14/Exit)
Secondary	Inflammatory Lesions	Change from baseline in facial inflammatory lesion count	14 days (Day 1 (Baseline) and Day 14/Exit)