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Mirvaso in Use Study

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ClinicalTrials.gov Identifier: NCT02249065
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : October 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE September 25, 2014
Results First Submitted Date  ICMJE September 19, 2017
Results First Posted Date  ICMJE October 19, 2017
Last Update Posted Date December 19, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Pre-Treatment Clinician Erythema Assessment (CEA) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
Clinician Erythema Assessment (CEA) [ Time Frame: 14 days ]
The number and percent of subjects in each CEA score category at each visit
Change History Complete list of historical versions of study NCT02249065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Subject Facial Redness Questionnaire [ Time Frame: 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)
  • Subject Treatment Satisfaction Questionnaire [ Time Frame: 14 days (Day 14/Exit) ]
    Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
  • Facial Redness Visual Analog Scale (VAS) [ Time Frame: 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
  • Inflammatory Lesions [ Time Frame: 14 days (Day 1 (Baseline) and Day 14/Exit) ]
    Change from baseline in facial inflammatory lesion count
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
  • Subject Facial Redness Questionnaire [ Time Frame: 14 days ]
    The number and percent of subjects in each response category for each of the 12 individual items on the Subject Facial Redness Questionnaire
  • Subject Treatment Satisfaction Questionnaire [ Time Frame: 14 days ]
    The number and percent of subjects in each response category for each of the 11 individual items on the Subject Treatment Satisfaction Questionnaire
  • Facial redness VAS [ Time Frame: 14 days ]
    The number and percent of subjects in each transformed response category for the in-office subject repmted facial redness VAS
  • Inflammatory Lesions [ Time Frame: 14 days ]
    The change and percent change form baseline in facial inflammatory lesion count
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mirvaso in Use Study
Official Title  ICMJE MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rosacea
Intervention  ICMJE Drug: Brimonidine
Other Name: Mirvaso Gel
Study Arms  ICMJE Experimental: Mirvaso Gel
Brimonidine topical gel, 0.33%
Intervention: Drug: Brimonidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2016)
205
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2014)
250
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02249065
Other Study ID Numbers  ICMJE GLI.04.SPR.US 10305
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Sugarman, MD Redwood Dermatology Center
PRS Account Galderma Laboratories, L.P.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP