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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01885000
Other study ID # RD.03.SPR.29107
Secondary ID 2012-005686-12
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1, 2013
Est. completion date November 14, 2013

Study information

Verified date August 2021
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date November 14, 2013
Est. primary completion date November 14, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Brimonidine tartrate was applied cutaneously once daily for 8 days.

Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.


Locations

Country Name City State
Germany Klinik für Dermatologie, Venerologie und Allergologie Berlin
Germany Universitätsklinikum Düsseldorf 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
Sweden Capio Citykliniken Lund
Sweden Läkarhuset Odenplan Stockholm
United Kingdom NHS Tayside Dundee
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

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Countries where clinical trial is conducted

Germany,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
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. Day 8
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. Day 8
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. Day 8
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. Baseline, Day 8
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. Day 8
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. Day 8
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. Day 8
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. Day 8
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. From start of study drug administration up to Day 8
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