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Patient-Reported Outcome Of Facial Erythema (PROOF) (PROOF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885000
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : January 13, 2017
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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.

Condition or disease Intervention/treatment Phase
Rosacea Erythema Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days. Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days. Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : July 1, 2013
Actual Primary Completion Date : November 14, 2013
Actual Study Completion Date : November 14, 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

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.



Primary Outcome Measures :
  1. Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment [ Time Frame: Day 8 ]
    Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.

  2. Percentage of Participants With Facial Redness Questionnaire at Day 8 [ Time Frame: 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.

  3. EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8 [ Time Frame: 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.

  4. Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8 [ Time Frame: 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.

  5. 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 [ Time Frame: 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 :
  1. Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA) [ Time Frame: 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.

  2. Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment [ Time Frame: 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.

  3. Change From Baseline in Facial Inflammatory Lesion Counts at Day 8 [ Time Frame: Day 8 ]
    Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator.

  4. Number of Participants Reported Adverse Events [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885000


Locations
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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, Germany
Sweden
Capio Citykliniken
Lund, Sweden
Läkarhuset Odenplan
Stockholm, Sweden
United Kingdom
NHS Tayside
Dundee, United Kingdom, DD1 9SY
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
Sponsors and Collaborators
Galderma R&D
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01885000    
Other Study ID Numbers: RD.03.SPR.29107
2012-005686-12 ( EudraCT Number )
First Posted: June 24, 2013    Key Record Dates
Results First Posted: January 13, 2017
Last Update Posted: August 25, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Rosacea
Erythema
Skin Diseases
Skin Manifestations
Brimonidine Tartrate
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs