Patient-Reported Outcome Of Facial Erythema (PROOF)
Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT01885000
Collaborator
(none)
92
14
2
4.5
6.6
1.5
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.
Study Design
Study Type:
Interventional
Actual Enrollment
:
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea
Actual Study Start Date
:
Jul 1, 2013
Actual Primary Completion Date
:
Nov 14, 2013
Actual Study Completion Date
:
Nov 14, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brimonidine tartrate 0.5% gel Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. |
Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.
|
| Placebo Comparator: Vehicle Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment [Day 8]
Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.
- Percentage of Participants With Facial Redness Questionnaire at Day 8 [Day 8]
Percentage of participants for each category of facial redness questionnaire on Day 8 was reported. Facial redness questionnaire included 12 questions/categories 1. Satisfied with appearance, 2. Appearance acceptable, 3. Appearance concerned, 4. Embarrassed with facial redness, 5. Self-conscious, 6. Frequency control last 24 hours, 7. Frustrated, 8. Cover up or camouflage, 9. Pay attention to the known triggers, 10. Avoid the known triggers, 11. Interfering with social life, 12. Interfering with work life.
- EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8 [Day 8]
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
- Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8 [Baseline, Day 8]
DLQI was a compact health-related quality of life index that has 10 questions and depends on the participants self-declaration about experiences during the previous week. DLQI results range between grades 0 and 30. [Grade 0-1]: No effect at all on participant's life, [Grade 2-5]: Small effect at all on participant's life, [Grade 6-10]: Moderate effect at all on participant's life, [Grade 11-20]: Very large effect at all on participant's life, [Grade 21-30]: Extremely large effect at all on participant's life. As the DLQI scores increase, the impact of the studied disease on life becomes greater.
- Euro Quality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along With a Visual Analogue Score for the Overall Health State) at Day 8 [Day 8]
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
Secondary Outcome Measures
- Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA) [Day 8]
Evaluation of erythema by using CEA was assessed by 0 to 4 grades, where 0-Clear skin with no signs of erythema, 1- Almost clear; slight redness, 2-Mild erythema; definite redness, 3-Moderate erythema; marked redness, 4-Severe erythema; fiery redness. Percentage of participants with at least two grade improvement in the CEA was reported.
- Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment [Day 8]
Percentage of participants with at least two grade improvement in the PSA was reported. Evaluation of erythema severity by using the PSA grades (0-4): 0- No redness, 1- very mild redness, 2-mild redness, 3-moderate redness, 4-severe redness.
- Change From Baseline in Facial Inflammatory Lesion Counts at Day 8 [Day 8]
Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator.
- Number of Participants Reported Adverse Events [From start of study drug administration up to Day 8]
All clinical medical events, whether observed by the investigator or reported by the participant and whether or not thought to be product- or study procedure-related were considered as adverse events.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female subjects age of 18 years or older
-
A clinical diagnosis of facial rosacea
-
A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug application
-
A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application
Exclusion Criteria:
-
More than 5 facial inflammatory lesions (papules or pustules) of rosacea
-
Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator
-
Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure)
-
Female who is pregnant or lactating
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinik für Dermatologie, Venerologie und Allergologie | Berlin | Germany | ||
| 2 | Universitätsklinikum Düsseldorf | Düsseldorf | Germany | ||
| 3 | Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt am Main | Germany | ||
| 4 | Universitätsklinikum Münster, Klinik für Hautkrankheiten | Münster | Germany | ||
| 5 | Universitäts-Hautklinik Eberhard Karls Universität Tübingen | Tübingen | Germany | ||
| 6 | CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH) | Wuppertal | Germany | ||
| 7 | Zentrum für Dermatologie, Allergologie und Dermatochirurgie | Wuppertal | Germany | ||
| 8 | Capio Citykliniken | Lund | Sweden | ||
| 9 | Läkarhuset Odenplan | Stockholm | Sweden | ||
| 10 | NHS Tayside | Dundee | United Kingdom | DD1 9SY | |
| 11 | University Hospitals of Leicester | Leicester | United Kingdom | ||
| 12 | Royal Free Hospital | London | United Kingdom | ||
| 13 | Whipps Cross University Hospital | London | United Kingdom | ||
| 14 | Harrogate District Hospital | Yorkshire | United Kingdom |
Sponsors and Collaborators
- Galderma R&D
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01885000
Other Study ID Numbers:
- RD.03.SPR.29107
- 2012-005686-12
First Posted:
Jun 24, 2013
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Study Results
Participant Flow
| Recruitment Details | This study was conducted at fourteen centers in Germany, Sweden, United Kingdom from 01 July 2013 (first participant visit) to 14 November 2013 (last participant completed). |
|---|---|
| Pre-assignment Detail | A total of 92 participants were randomized, of which 88 participants completed the study. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Period Title: Overall Study | ||
| STARTED | 48 | 44 |
| COMPLETED | 46 | 42 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle | Total |
|---|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. | Total of all reporting groups |
| Overall Participants | 48 | 44 | 92 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.4
(12.9)
|
54.9
(12.8)
|
54.1
(12.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
30
62.5%
|
26
59.1%
|
56
60.9%
|
| Male |
18
37.5%
|
18
40.9%
|
36
39.1%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
48
100%
|
44
100%
|
92
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Skin phototype (Count of Participants) | |||
| Type I |
3
6.3%
|
6
13.6%
|
9
9.8%
|
| Type II |
34
70.8%
|
27
61.4%
|
61
66.3%
|
| Type III |
11
22.9%
|
11
25%
|
22
23.9%
|
Outcome Measures
| Title | Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment |
|---|---|
| Description | Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported. |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here over all number of participants 'N' analyzed signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 46 | 42 |
| Number [Percentage of participants] |
69.6
145%
|
40.4
91.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.0065 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Percentage of Participants With Facial Redness Questionnaire at Day 8 |
|---|---|
| Description | Percentage of participants for each category of facial redness questionnaire on Day 8 was reported. Facial redness questionnaire included 12 questions/categories 1. Satisfied with appearance, 2. Appearance acceptable, 3. Appearance concerned, 4. Embarrassed with facial redness, 5. Self-conscious, 6. Frequency control last 24 hours, 7. Frustrated, 8. Cover up or camouflage, 9. Pay attention to the known triggers, 10. Avoid the known triggers, 11. Interfering with social life, 12. Interfering with work life. |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here over all number of participants 'N' analyzed signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 46 | 42 |
| 1. Very dissatisfied/ Dissatisfied |
45.7
95.2%
|
69.0
156.8%
|
| 1. Dissatisfied or Satisfied/Satisfied |
54.3
113.1%
|
31.0
70.5%
|
| 2. Very unacceptable/Unacceptable |
47.9
99.8%
|
59.5
135.2%
|
| 2.Acceptable or Unacceptable/Acceptable |
52.1
108.5%
|
40.5
92%
|
| 3.Not at all/Slightly |
28.2
58.8%
|
21.4
48.6%
|
| 3. Somewhat /Moderately /Extremely |
71.7
149.4%
|
78.6
178.6%
|
| 4. Not at all |
28.3
59%
|
9.5
21.6%
|
| 4. Slightly/ Somewhat/Moderately/Extremely |
71.7
149.4%
|
90.4
205.5%
|
| 5.Not at all/Slightly/ Somewhat |
73.4
152.9%
|
47.6
108.2%
|
| 5. Moderately/Extremely |
26.7
55.6%
|
52.3
118.9%
|
| 6. Not at all |
23.9
49.8%
|
31.7
72%
|
| 6.Slightly/Somewhat/Moderately/Extremel y |
76.1
158.5%
|
68.2
155%
|
| 7. Not at all |
8.7
18.1%
|
14.3
32.5%
|
| 7. Slightly/Somewhat/Moderately/Extremely |
91.2
190%
|
85.8
195%
|
| 8.Not at all |
60.9
126.9%
|
61.9
140.7%
|
| 8. Slightly/Somewhat |
23.9
49.8%
|
11.9
27%
|
| 9. Not at all/Rarely |
47.8
99.6%
|
48.8
110.9%
|
| 9.Some of the time/Often/Constantly |
52.2
108.8%
|
51.2
116.4%
|
| 10.Not at all/Rarely |
47.8
99.6%
|
47.6
108.2%
|
| 10. Some of the time/Often/Constantly |
52.2
108.8%
|
52.4
119.1%
|
| 11. Not at all |
34.8
72.5%
|
21.4
48.6%
|
| 11.Slightly/Somewhat/Moderately/Extremely |
65.2
135.8%
|
78.5
178.4%
|
| 12.Not at all |
26.7
55.6%
|
23.8
54.1%
|
| 12.Slight/Somewhat/Moderate/Extreme/ Not Applicable/I'm not working |
73.4
152.9%
|
76.2
173.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who satisfied with appearance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.0328 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who appearance acceptable. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.5312 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who appearance concerned. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.0756 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who embarrassed with facial redness. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.0083 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who self-conscious. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.0076 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who's frequency control last 24 hours | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.2186 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who are frustrated. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.2373 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who cover up or camouflage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.7769 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who pay attention to the known triggers. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.8764 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who avoid the known triggers. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.6149 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | The questionnaire analyzed and reported here is for participants who interfering with social life. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.8361 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | Interfering with work life | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.6259 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8 |
|---|---|
| Description | EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement. |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific categories. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 46 | 42 |
| 1. I have no problems in walking about |
95.7
199.4%
|
92.9
211.1%
|
| 1.I have some problems in walking about |
4.3
9%
|
7.1
16.1%
|
| 2. I have no problems with self-care |
97.8
203.8%
|
97.6
221.8%
|
| 2. I have some problems washing or dressing myself |
2.2
4.6%
|
2.4
5.5%
|
| 3.I have no problems with performing usual activity |
91.3
190.2%
|
90.5
205.7%
|
| 3.I have some problems with performing usual activity |
8.7
18.1%
|
9.5
21.6%
|
| 4.I have no pain or discomfort |
58.7
122.3%
|
76.2
173.2%
|
| 4.I have moderate pain or discomfort |
41.3
86%
|
21.4
48.6%
|
| 4.I have extreme pain or discomfort |
0
0%
|
2.4
5.5%
|
| 5.I am not anxious or depressed |
87.0
181.3%
|
73.8
167.7%
|
| 5.I am moderately anxious or depressed |
10.9
22.7%
|
26.2
59.5%
|
| 5.I am extremely anxious or depressed |
2.2
4.6%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | This analysis was performed for Mobility. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.5821 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | This analysis was performed for Self-Care. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.8864 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | This analysis was performed for usual activities. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.9579 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | This analysis was performed for Pain/Discomfort. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.1344 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | Anxiety/Depression | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.1881 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8 |
|---|---|
| Description | DLQI was a compact health-related quality of life index that has 10 questions and depends on the participants self-declaration about experiences during the previous week. DLQI results range between grades 0 and 30. [Grade 0-1]: No effect at all on participant's life, [Grade 2-5]: Small effect at all on participant's life, [Grade 6-10]: Moderate effect at all on participant's life, [Grade 11-20]: Very large effect at all on participant's life, [Grade 21-30]: Extremely large effect at all on participant's life. As the DLQI scores increase, the impact of the studied disease on life becomes greater. |
| Time Frame | Baseline, Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 45 | 41 |
| Mean (Standard Deviation) [percent change] |
-15.4
(61.7)
|
-32.6
(43.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.3935 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Euro Quality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along With a Visual Analogue Score for the Overall Health State) at Day 8 |
|---|---|
| Description | EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement. |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 45 | 42 |
| Mean (Standard Deviation) [Score on scale] |
76.0
(19.3)
|
80.2
(13.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brimonidine Tartrate 0.5% Gel, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.4162 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA) |
|---|---|
| Description | Evaluation of erythema by using CEA was assessed by 0 to 4 grades, where 0-Clear skin with no signs of erythema, 1- Almost clear; slight redness, 2-Mild erythema; definite redness, 3-Moderate erythema; marked redness, 4-Severe erythema; fiery redness. Percentage of participants with at least two grade improvement in the CEA was reported. |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 46 | 42 |
| Number [Percentage of participants] |
47.8
99.6%
|
7.1
16.1%
|
| Title | Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment |
|---|---|
| Description | Percentage of participants with at least two grade improvement in the PSA was reported. Evaluation of erythema severity by using the PSA grades (0-4): 0- No redness, 1- very mild redness, 2-mild redness, 3-moderate redness, 4-severe redness. |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 46 | 42 |
| Number [Percentage of participants] |
41.3
86%
|
23.8
54.1%
|
| Title | Change From Baseline in Facial Inflammatory Lesion Counts at Day 8 |
|---|---|
| Description | Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator. |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 46 | 42 |
| Mean (Standard Deviation) [number of lesions] |
0.3
(2.5)
|
0.4
(1.4)
|
| Title | Number of Participants Reported Adverse Events |
|---|---|
| Description | All clinical medical events, whether observed by the investigator or reported by the participant and whether or not thought to be product- or study procedure-related were considered as adverse events. |
| Time Frame | From start of study drug administration up to Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Patient Treated (APT) population included all participants enrolled in the study who had received the study treatment at least once. |
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle |
|---|---|---|
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Measure Participants | 48 | 44 |
| Count of Participants [Participants] |
15
31.3%
|
9
20.5%
|
Adverse Events
| Time Frame | From start of study drug administration up to Day 8 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Brimonidine Tartrate 0.5% Gel | Vehicle | ||
| Arm/Group Description | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. | ||
All Cause Mortality |
||||
| Brimonidine Tartrate 0.5% Gel | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/48 (0%) | 0/44 (0%) | ||
Serious Adverse Events |
||||
| Brimonidine Tartrate 0.5% Gel | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/48 (0%) | 0/44 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Brimonidine Tartrate 0.5% Gel | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/48 (31.3%) | 9/44 (20.5%) | ||
| Infections and infestations | ||||
| Rash pustular | 2/48 (4.2%) | 2 | 0/44 (0%) | 0 |
| Nasopharyngitis | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 1/48 (2.1%) | 1 | 2/44 (4.5%) | 2 |
| Hypoesthesia | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/48 (2.1%) | 1 | 1/44 (2.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Erythema | 6/48 (12.5%) | 6 | 2/44 (4.5%) | 2 |
| Pain of skin | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Pruritus | 1/48 (2.1%) | 1 | 1/44 (2.3%) | 1 |
| Rosacea | 2/48 (4.2%) | 2 | 1/44 (2.3%) | 1 |
| Skin burning sensation | 0/48 (0%) | 0 | 2/44 (4.5%) | 2 |
| Skin irritation | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Skin tightness | 4/48 (8.3%) | 5 | 2/44 (4.5%) | 3 |
| Skin warm | 2/48 (4.2%) | 9 | 1/44 (2.3%) | 2 |
| Swelling face | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Vascular disorders | ||||
| Flushing | 2/48 (4.2%) | 2 | 0/44 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Disclosure agreement covered by contract.
Results Point of Contact
| Name/Title | Clinical Operations |
|---|---|
| Organization | Galderma |
| Phone | 817 961 5000 ext +1 |
| Clinical.Studies@galderma.com |
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01885000
Other Study ID Numbers:
- RD.03.SPR.29107
- 2012-005686-12
First Posted:
Jun 24, 2013
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021