RosaceaPhase 3PROOFNCT01885000
Patient-Reported Outcome Of Facial Erythema (PROOF)
A Phase 3 study testing Brimonidine tartrate was applied cutaneously once daily for 8 days. in people with Rosacea and Erythema, run by Galderma R&D at 14 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Brimonidine tartrate was applied cutaneously once daily for 8 days.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 1 Jul 2013to 14 Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Germany7 sites
Klinik für Dermatologie, Venerologie und Allergologie
Berlin
Universitätsklinikum Düsseldorf
Düsseldorf
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main
Universitätsklinikum Münster, Klinik für Hautkrankheiten
Münster
Universitäts-Hautklinik Eberhard Karls Universität Tübingen
Tübingen
CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH)
Wuppertal
Zentrum für Dermatologie, Allergologie und Dermatochirurgie
Wuppertal
United Kingdom5 sites
NHS Tayside
Dundee, DD1 9SY
University Hospitals of Leicester
Leicester
Royal Free Hospital
London
Whipps Cross University Hospital
London
Harrogate District Hospital
Yorkshire
About this study
Official title: Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea
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.
- Being tested
- Brimonidine tartrate was applied cutaneously once daily for 8 days., Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
- Medical subject headings
- Rosacea, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine tartrate was applied cutaneously once daily for 8 days.Drug
Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.Drug
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine tartrate 0.5% gel | Experimental | Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. Receives: Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days. |
| Vehicle | Placebo comparator | Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. Receives: Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From start of study drug administration up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study start1 Jul 2013
- Primary completion14 Nov 2013
- Study completion14 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885000
- Sponsor's protocol ID
- RD.03.SPR.29107
- Other IDs
- 2012-005686-12
- Acronym
- PROOF
- Status last verified
- Aug 2021
- First submitted
- 20 Jun 2013
- Last updated
- 25 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 26416154
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea
- ClinicalTrials.gov ID
- NCT01885000
- Acronym / sponsor ID
- PROOF / RD.03.SPR.29107
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 14 Nov 2013 (actual)
- Study completion
- 14 Nov 2013 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Posted 13 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brimonidine tartrate 0.5% gel | Experimental | Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. |
| Vehicle | Placebo comparator | Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brimonidine tartrate was applied cutaneously once daily for 8 days. | Drug | Brimonidine tartrate 0.5% gel |
| Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days. | Drug | Vehicle |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)
Time frame: Day 8
Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment
Time frame: Day 8
Change From Baseline in Facial Inflammatory Lesion Counts at Day 8
Time frame: Day 8
Number of Participants Reported Adverse Events
Time frame: From start of study drug administration up to Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26416154Layton 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brimonidine tartrate was applied cutaneously once daily for 8 days. in people with Rosacea and Erythema, run by Galderma R&D at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, United Kingdom, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment (time frame: Day 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.