RosaceaPhase 4NCT07431476
Brimonidine 0.33% for Rosacea-Related Facial Erythema
A Phase 4 study testing Brimonidine 0.33% gel in people with Rosacea and Rosacea Subtype 1 (Erythematotelangiectatic), run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study looks at whether a topical gel called 0.33% brimonidine can reduce persistent facial redness caused by rosacea. The study was carried out in two parts. In the first part, the gel was applied to only one side of each participant's face, while the other side received a placebo (a non-active gel). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Rosacea Subtype 1 (Erythematotelangiectatic)
- What is being tested?
- Brimonidine 0.33% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 7 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Adults aged 18 years or older
- Clinical diagnosis of erythematotelangiectatic rosacea (ETR) according to the National Rosacea Society (NRS) diagnostic criteria
- Presence of persistent facial erythema consistent with ETR
- Symmetrical facial involvement adequate for split-face assessment
- No more than two inflammatory facial lesions at screening
- Ability and willingness to comply with all study procedures, including acute Day 1 assessments and the 1-month follow-up visit
- Willingness to apply topical brimonidine gel daily during the 1-month period and to avoid initiating new rosacea treatments during the study
- Provision of written informed consent
Who cannot join
- Individuals younger than 18 years.
- Presence of three or more inflammatory facial lesions.
- Prior use of BT (brimonidine tartrate) for facial erythema.
- Use of topical or systemic treatments for rosacea or other dermatoses without completing the required washout period.
- Presence of other facial dermatoses
- Withdrawal of consent (the only discontinuation criterion)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital, Department of Dermatology
Istanbul, 34098
About this study
Official title: Acute and Short-Term Efficacy of 0.33% Brimonidine in Persistent Erythema of Rosacea: A Prospective Two-Phase Study Incorporating a Split-Face, Randomized, Placebo-Controlled Design and Objective Biophysical and Dermoscopic Assessments
This study looks at whether a topical gel called 0.33% brimonidine can reduce persistent facial redness caused by rosacea. The study was carried out in two parts.
In the first part, the gel was applied to only one side of each participant's face, while the other side received a placebo (a non-active gel). Redness was measured before and after application to see the immediate (short-term) effect.
Read more
In the second part, participants used brimonidine gel on both sides of the face once daily for one month. Redness and visible blood vessel changes were checked again at the end of this period.
Redness was evaluated using objective measurements of skin color, dermoscopic (magnified) images of facial blood vessels, and patient-reported symptoms such as burning or stinging.
The purpose of this study is to understand both the short-term and one-month effects of 0.33% brimonidine gel on persistent facial redness in people with rosacea.
Read the detailed description
This prospective, two-phase clinical study was designed to evaluate the acute and short-term effects of 0.33% brimonidine gel on persistent facial erythema associated with rosacea. The study included an acute phase using a split-face, randomized, placebo-controlled methodology, followed by a one-month open-label phase.
In the acute phase, each participant received brimonidine gel on one half of the face and a placebo gel on the opposite side. The assignment of treatment sides was randomized for each participant. Erythema measurements were obtained at baseline (0 hour) and again one hour after application to assess the immediate vasoconstrictive effect of brimonidine. Dermoscopic imaging was performed to evaluate vascular morphology, including erythema intensity, vascular density, vessel caliber, and the area of involvement. These dermoscopic parameters were scored using predefined semi-quantitative scales developed for this study.
In the second phase, all participants applied 0.33% brimonidine gel once daily to the entire face for one month. At the end of the one-month period, erythema measurements and dermoscopic evaluations were repeated before and one hour after application to determine whether the acute response to brimonidine changed with continuous daily use. Patient-reported outcomes, including burning, stinging, and other treatment-related symptoms, were also recorded during both phases.
Objective erythema was quantified using a biophysical measurement device (erythema index), which provided standardized and reproducible assessments of skin redness. The use of both biophysical measurements and dermoscopic visualization allowed for a comprehensive evaluation of the drug's clinical and vascular effects.
No investigational new drug application (IND) was involved, and the product used was a commercially available formulation of brimonidine. All study procedures were performed under ethics committee approval, and written informed consent was obtained from all participants.
- Being tested
- Brimonidine 0.33% gel, Placebo gel
- Keywords
- Rosacea, Persistent Erythema, Brimonidine, Brimonidine 0.33% Gel, Topical Vasoconstrictor, Split-Face Study, Randomized Controlled, Prospective Study, Dermoscopy, Vascular Density, Erythema Index, Patient-Reported Outcomes, Skindex-16, Hospital Anxiety and Depression Scale (HADS), Mexameter, Paradoxical Erythema, Rebound Erythema, Erythematotelangiectatic Rosacea, ETR, Rosacea Subtype I
- Medical subject headings
- Rosacea, Depression, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine 0.33% gelDrug
Topical brimonidine tartrate 0.33% gel applied to one randomized facial half during the acute split-face phase. After completion of the acute assessment, all participants enter a 1-month open-label phase with once-daily full-face application.
Placebo gelDrug
Vehicle gel identical in appearance and texture to the active formulation, applied to the contralateral facial half during the acute split-face phase only.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Brimonidine 0.33% Gel | Experimental | Facial half randomized to receive topical brimonidine tartrate 0.33% gel during the acute split-face phase. Receives: Drug: Brimonidine 0.33% gel |
| Placebo Comparator: Vehicle Gel | Placebo comparator | Contralateral facial half randomized to receive vehicle gel during the acute split-face phase. Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erythema Index (EI) measured with Mexameter (MX18)
The primary outcome is the change in objective erythema values measured using the Mexameter (MX18) device. Acute effects will be assessed by comparing EI measurements at baseline (0 hour), 1 hour, and 3 hours after the single split-face application of brimonidine versus placebo on Day 1. Short-term effects will be assessed at the 1-month visit by comparing EI values at 0 hour and 1 hour following 1 month of daily home use of brimonidine. Higher EI values indicate greater erythema.
Measured: Baseline (0 hour), 1 hour, and 3 hours on Day 1; and 0 hour and 1 hour at the 1-month visit
Secondary outcomes (7)
Dermoscopy Erythema Intensity Score (DEYS)
Semi-quantitative dermoscopic score evaluating erythema intensity on a predefined 0-4 scale. Higher scores indicate greater erythema intensity.
Measured: Day 1: 0 hour and 1 hour; and Month 1: 0 hour and 1 hour
Clinical Erythema Score (0-4 Scale)
The Clinical Erythema Score (CES) is a semi-quantitative 0-4 scale used to assess the severity of visible facial erythema. A score of 0 indicates no erythema, 1 mild erythema, 2 moderate erythema, 3 marked erythema, and 4 severe/intense erythema. Assessments are performed at Day 1 (0 hour, 1 hour, and 3 hours after the split-face application) and at the 1-month visit (0 hour and 1 hour) following daily home use of brimonidine. Higher scores indicate more pronounced clinical erythema.
Measured: Day 1: 0 hour, 1 hour, and 3 hours; and Month 1: 0 hour and 1 hour
Patient Self-Assessment of Facial Redness (0-4 Scale)
Participants rate the severity of their facial redness using a 0-4 self-assessment scale. A score of 0 indicates no redness, 1 mild redness, 2 moderate redness, 3 marked redness, and 4 severe/intense redness. Assessments are performed at Day 1 (0 hour, 1 hour, and 3 hours after split-face application) and at the 1-month visit (0 hour and 1 hour) following daily home use of brimonidine. Higher scores indicate greater patient-perceived redness.
Measured: Day 1: 0 hour, 1 hour, and 3 hours; and Month 1: 0 hour and 1 hour
Hospital Anxiety and Depression Scale (HADS) Total Psychological Impact
The psychological impact of rosacea-related facial erythema is assessed using the Hospital Anxiety and Depression Scale (HADS), which includes two subscores: Anxiety (HADS-A) and Depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating more severe symptoms. The scale is administered at baseline and at the 1-month visit to evaluate whether changes in erythema severity are associated with changes in anxiety or depressive symptoms.
Measured: Baseline and Month 1
Skindex-16 Dermatology Quality of Life Score
Dermatology-specific quality of life is assessed using the Skindex-16 questionnaire, which includes three domains: Symptoms, Emotions, and Functioning. Each item is scored from 0 to 6, with higher scores indicating greater impairment. Total and domain scores are recorded at baseline and at the 1-month visit to evaluate changes in quality of life related to improvements in facial erythema.
Measured: Baseline and Month 1
Dermoscopy Vessel Density Area Score (DDYAS)
Semi-quantitative dermoscopic score assessing vascular density in the evaluated facial region. Higher scores indicate greater vessel density.
Measured: Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour)
Average Vessel Thickness Score (ODKS)
Semi-quantitative dermoscopic score assessing average vessel thickness. Higher scores indicate thicker vessels.
Measured: Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 May 2025
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "This study uses a single-group, split-face design in which each participant receives 0.33% brimonidine gel on one side of the face and a placebo gel on the opposite side. Treatment sides were randomized for each participant. This within-subject model allows direct comparison of the acute effects of the active drug versus placebo under identical individual conditions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yavuz Selim Pilis, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431476
- Sponsor's protocol ID
- SBU-IEAH-DER-BRIM-ROS-01
- Other IDs
- Medipol-EC-502
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fowler J Jr, Jackson M, Moore A, Jarratt M, Jones T, Meadows K, Steinhoff M, Rudisill D, Leoni M. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol. 2013 Jun 1;12(6):650-6.
PubMed 23839181
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Short-Term Efficacy of 0.33% Brimonidine in Persistent Erythema of Rosacea: A Prospective Two-Phase Study Incorporating a Split-Face, Randomized, Placebo-Controlled Design and Objective Biophysical and Dermoscopic Assessments
- ClinicalTrials.gov ID
- NCT07431476
- Acronym / sponsor ID
- SBU-IEAH-DER-BRIM-ROS-01
- Keywords
- Rosacea, Persistent Erythema, Brimonidine, Brimonidine 0.33% Gel, Topical Vasoconstrictor, Split-Face Study, Randomized Controlled, Prospective Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at whether a topical gel called 0.33% brimonidine can reduce persistent facial redness caused by rosacea. The study was carried out in two parts.
In the first part, the gel was applied to only one side of each participant's face, while the other side received a placebo (a non-active gel). Redness was measured before and after application to see the immediate (short-term) effect.
In the second part, participants used brimonidine gel on both sides of the face once daily for one month. Redness and visible blood vessel changes were checked again at the end of this period.
Redness was evaluated using objective measurements of skin color, dermoscopic (magnified) images of facial blood vessels, and patient-reported symptoms such as burning or stinging.
The purpose of this study is to understand both the short-term and one-month effects of 0.33% brimonidine gel on persistent facial redness in people with rosacea.
Detailed description
This prospective, two-phase clinical study was designed to evaluate the acute and short-term effects of 0.33% brimonidine gel on persistent facial erythema associated with rosacea. The study included an acute phase using a split-face, randomized, placebo-controlled methodology, followed by a one-month open-label phase.
In the acute phase, each participant received brimonidine gel on one half of the face and a placebo gel on the opposite side. The assignment of treatment sides was randomized for each participant. Erythema measurements were obtained at baseline (0 hour) and again one hour after application to assess the immediate vasoconstrictive effect of brimonidine. Dermoscopic imaging was performed to evaluate vascular morphology, including erythema intensity, vascular density, vessel caliber, and the area of involvement. These dermoscopic parameters were scored using predefined semi-quantitative scales developed for this study.
In the second phase, all participants applied 0.33% brimonidine gel once daily to the entire face for one month. At the end of the one-month period, erythema measurements and dermoscopic evaluations were repeated before and one hour after application to determine whether the acute response to brimonidine changed with continuous daily use. Patient-reported outcomes, including burning, stinging, and other treatment-related symptoms, were also recorded during both phases.
Objective erythema was quantified using a biophysical measurement device (erythema index), which provided standardized and reproducible assessments of skin redness. The use of both biophysical measurements and dermoscopic visualization allowed for a comprehensive evaluation of the drug's clinical and vascular effects.
No investigational new drug application (IND) was involved, and the product used was a commercially available formulation of brimonidine. All study procedures were performed under ethics committee approval, and written informed consent was obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- "This study uses a single-group, split-face design in which each participant receives 0.33% brimonidine gel on one side of the face and a placebo gel on the opposite side. Treatment sides were randomized for each participant. This within-subject model allows direct comparison of the acute effects of the active drug versus placebo under identical individual conditions.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Brimonidine 0.33% Gel | Experimental | Drug: Brimonidine 0.33% gelFacial half randomized to receive topical brimonidine tartrate 0.33% gel during the acute split-face phase. |
| Placebo Comparator: Vehicle Gel | Placebo comparator | Drug: Placebo gelContralateral facial half randomized to receive vehicle gel during the acute split-face phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older
- Clinical diagnosis of erythematotelangiectatic rosacea (ETR) according to the National Rosacea Society (NRS) diagnostic criteria
- Presence of persistent facial erythema consistent with ETR
- Symmetrical facial involvement adequate for split-face assessment
- No more than two inflammatory facial lesions at screening
Key exclusion criteria (6 listed)
- Individuals younger than 18 years.
- Presence of three or more inflammatory facial lesions.
- Prior use of BT (brimonidine tartrate) for facial erythema.
- Use of topical or systemic treatments for rosacea or other dermatoses without completing the required washout period.
- Presence of other facial dermatoses
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 0.33% gelTopical brimonidine tartrate 0.33% gel applied to one randomized facial half during the acute split-face phase. After completion of the acute assessment, all participants enter a 1-month open-label phase with once-daily full-face application. | Drug | Experimental: Brimonidine 0.33% Gel |
| Placebo gelVehicle gel identical in appearance and texture to the active formulation, applied to the contralateral facial half during the acute split-face phase only. | Drug | Placebo Comparator: Vehicle Gel |
Primary outcome
Change in Erythema Index (EI) measured with Mexameter (MX18)
Time frame: Baseline (0 hour), 1 hour, and 3 hours on Day 1; and 0 hour and 1 hour at the 1-month visit
The primary outcome is the change in objective erythema values measured using the Mexameter (MX18) device. Acute effects will be assessed by comparing EI measurements at baseline (0 hour), 1 hour, and 3 hours after the single split-face application of brimonidine versus placebo on Day 1. Short-term effects will be assessed at the 1-month visit by comparing EI values at 0 hour and 1 hour following 1 month of daily home use of brimonidine. Higher EI values indicate greater erythema.
7 secondary outcomes
Dermoscopy Erythema Intensity Score (DEYS)
Time frame: Day 1: 0 hour and 1 hour; and Month 1: 0 hour and 1 hour
Clinical Erythema Score (0-4 Scale)
Time frame: Day 1: 0 hour, 1 hour, and 3 hours; and Month 1: 0 hour and 1 hour
Patient Self-Assessment of Facial Redness (0-4 Scale)
Time frame: Day 1: 0 hour, 1 hour, and 3 hours; and Month 1: 0 hour and 1 hour
Hospital Anxiety and Depression Scale (HADS) Total Psychological Impact
Time frame: Baseline and Month 1
Skindex-16 Dermatology Quality of Life Score
Time frame: Baseline and Month 1
Dermoscopy Vessel Density Area Score (DDYAS)
Time frame: Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour)
Average Vessel Thickness Score (ODKS)
Time frame: Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Results publication: PubMed 23839181Fowler J Jr, Jackson M, Moore A, Jarratt M, Jones T, Meadows K, Steinhoff M, Rudisill D, Leoni M. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol. 2013 Jun 1;12(6):650-6.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brimonidine 0.33% gel in people with Rosacea and Rosacea Subtype 1 (Erythematotelangiectatic), run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Erythema Index (EI) measured with Mexameter (MX18) (time frame: Baseline (0 hour), 1 hour, and 3 hours on Day 1; and 0 hour and 1 hour at the 1-month visit). 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 NCT07431476, 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 24 Feb 2026.