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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rosacea
Intervention Drug: Brimonidine
Enrollment 205
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mirvaso Gel
Hide 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
Arm/Group Title Mirvaso Gel
Hide Arm/Group Description Brimonidine Gel
Overall Number of Baseline Participants 181
Hide Baseline Analysis Population Description
ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants
<=18 years
0
   0.0%
Between 18 and 65 years
143
  79.0%
>=65 years
38
  21.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 181 participants
52.4
(22.0 to 85.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants
Female
136
  75.1%
Male
45
  24.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 181 participants
181
 100.0%
1.Primary Outcome
Title Pre-Treatment Clinician Erythema Assessment (CEA)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Brimonidine Gel
Overall Number of Participants Analyzed 181
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 (Baseline) Clear Skin
0
   0.0%
Almost Clear
0
   0.0%
Mild Erythema
7
   3.9%
Moderate Erythema
144
  79.6%
Severe Erythema
30
  16.6%
Missing
0
   0.0%
Day 7 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%
Day 14 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
   0.0%
2.Secondary Outcome
Title Subject Facial Redness Questionnaire
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Brimonidine Gel
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Participants
Not Bothered (Mean [SD], Day 1, Baseline) 75.3  (39.4)
Bothered (Mean [SD], Day 1, Baseline) 104.7  (40.3)
Missing (Day 1, Baseline) 1  (0)
Not Bothered (Mean [SD], Day 14) 112.6  (28.9)
Bothered (Mean [SD], Day 14) 67.3  (26.2)
Missing (Day 14) 1.1  (.3)
3.Secondary Outcome
Title Subject Treatment Satisfaction Questionnaire
Hide Description Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
Time Frame 14 days (Day 14/Exit)
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Brimonidine Gel
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Participants
Satisfied Participants (Mean [SD]) 127.3  (22.2)
Dissatisfied Participants (Mean [SD]) 52.7  (22.2)
Missing 1.0  (0.0)
4.Secondary Outcome
Title Facial Redness Visual Analog Scale (VAS)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Brimonidine Gel
Overall Number of Participants Analyzed 181
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 None
1
   0.6%
Very Mild
31
  17.1%
Mild
57
  31.5%
Moderate
48
  26.5%
Severe
38
  21.0%
Very Severe
6
   3.3%
Day 14 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
Hide Description Change from baseline in facial inflammatory lesion count
Time Frame 14 days (Day 1 (Baseline) and Day 14/Exit)
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Brimonidine Gel
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: lesions
Day 1: Lesions .6  (1.2)
Day 14: Lesions 1.5  (4.4)
Day 14: Change From Baseline 1  (3.9)
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
Hide Arm/Group Description Brimonidine Gel
All-Cause Mortality
Mirvaso Gel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mirvaso Gel
Affected / at Risk (%)
Total   3/181 (1.66%) 
Cardiac disorders   
myocardial infarction  1  1/181 (0.55%) 
Pericarditis  1  1/181 (0.55%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/181 (0.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Mirvaso Gel
Affected / at Risk (%)
Total   68/181 (37.57%) 
General disorders   
condition aggravated  1  33/181 (18.23%) 
feeling hot  1  4/181 (2.21%) 
Infections and infestations   
nasopharyngitis  1  6/181 (3.31%) 
Skin and subcutaneous tissue disorders   
rosacea  1  21/181 (11.60%) 
Erythema  1  7/181 (3.87%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jean Philippe York
Organization: Galderma Laboratories L.P.
Phone: 817-961-5468
EMail: jp.york@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02249065     History of Changes
Other Study ID Numbers: GLI.04.SPR.US 10305
First Submitted: September 23, 2014
First Posted: September 25, 2014
Results First Submitted: September 19, 2017
Results First Posted: October 19, 2017
Last Update Posted: December 19, 2017