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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005686-12 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brimonidine tartrate 0.5% gel | Experimental | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. |
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| Vehicle | Placebo Comparator | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine tartrate was applied cutaneously once daily for 8 days. | Drug |
| ||
| Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment | Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported. | Day 8 |
| Percentage of Participants With Facial Redness Questionnaire at 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. | Day 8 |
| EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at 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. | Day 8 |
| Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Dermatologie, Venerologie und Allergologie | Berlin | Germany | ||||
| Universitätsklinikum Düsseldorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26416154 | Derived | Layton AM, Schaller M, Homey B, Hofmann MA, Bewley AP, Lehmann P, Nohlgard C, Sarwer DB, Kerrouche N, Ma YM. Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study. J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2405-10. doi: 10.1111/jdv.13305. Epub 2015 Sep 28. |
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A total of 92 participants were randomized, of which 88 participants completed the study.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Brimonidine Tartrate 0.5% Gel | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. |
| FG001 | Vehicle | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| Baseline, Day 8 |
| 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 | 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. | Day 8 |
| Day 8 |
| Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment | 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. | Day 8 |
| Change From Baseline in Facial Inflammatory Lesion Counts at Day 8 | Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator. | Day 8 |
| Number of Participants Reported Adverse Events | 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. | From start of study drug administration up to Day 8 |
| Düsseldorf |
| Germany |
| Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt am Main | Germany |
| Universitätsklinikum Münster, Klinik für Hautkrankheiten | Münster | Germany |
| Universitäts-Hautklinik Eberhard Karls Universität Tübingen | Tübingen | Germany |
| CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH) | Wuppertal | Germany |
| Zentrum für Dermatologie, Allergologie und Dermatochirurgie | Wuppertal | Germany |
| Capio Citykliniken | Lund | Sweden |
| Läkarhuset Odenplan | Stockholm | Sweden |
| NHS Tayside | Dundee | DD1 9SY | United Kingdom |
| University Hospitals of Leicester | Leicester | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| Whipps Cross University Hospital | London | United Kingdom |
| Harrogate District Hospital | Yorkshire | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) population consisted of the entire population enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brimonidine Tartrate 0.5% Gel | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. |
| BG001 | Vehicle | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Skin phototype | Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to III. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment | Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported. | 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. | Posted | Number | Percentage of participants | Day 8 |
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| Primary | Percentage of Participants With Facial Redness Questionnaire at 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. | 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. | Posted | Number | percentage of participants | Day 8 |
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| Primary | EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at 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. | 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. | Posted | Number | Percentage of participants | Day 8 |
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| Primary | Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 8 |
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| Primary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | Score on scale | Day 8 |
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| Secondary | Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA) | 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. | 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. | Posted | Number | Percentage of participants | Day 8 |
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| Secondary | Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment | 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. | 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. | Posted | Number | Percentage of participants | Day 8 |
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| Secondary | Change From Baseline in Facial Inflammatory Lesion Counts at Day 8 | Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator. | 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. | Posted | Mean | Standard Deviation | number of lesions | Day 8 |
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| Secondary | Number of Participants Reported Adverse Events | 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. | All Patient Treated (APT) population included all participants enrolled in the study who had received the study treatment at least once. | Posted | Count of Participants | Participants | From start of study drug administration up to Day 8 |
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From start of study drug administration up to Day 8
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brimonidine Tartrate 0.5% Gel | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | 0 | 48 | 0 | 48 | 15 | 48 |
| EG001 | Vehicle | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. | 0 | 44 | 0 | 44 | 9 | 44 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash pustular | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Skin warm | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Hypoesthesia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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Disclosure agreement covered by contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | +1 | Clinical.Studies@galderma.com |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Type II |
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| Type III |
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