A Phase 4 interventional study of Brimonidine 0.33% gel and Placebo gel in Rosacea and Rosacea Subtype 1 (Erythematotelangiectatic), sponsored by Istanbul Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Istanbul Training and Research Hospital · Phase 4, Interventional, and Treatment
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.
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 45 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Istanbul Training and Research Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Facial half randomized to receive topical brimonidine tartrate 0.33% gel during the acute split-face phase.
Drug: Brimonidine 0.33% gel
Contralateral facial half randomized to receive vehicle gel during the acute split-face phase.
Drug: Placebo gel
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.
Vehicle gel identical in appearance and texture to the active formulation, applied to the contralateral facial half during the acute split-face phase only.
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.
Time frame: Baseline (0 hour), 1 hour, and 3 hours on Day 1; and 0 hour and 1 hour at the 1-month visit
Dermoscopy Erythema Intensity Score (DEYS)
Semi-quantitative dermoscopic score evaluating erythema intensity on a predefined 0-4 scale. Higher scores indicate greater erythema intensity.
Time frame: 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.
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)
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour)
Plan to share: No
Ran from May 2025 to primary completion in Aug 2025, 3 months.
Of 12 phase 4 interventional studies under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brimonidine
Istanbul Training and Research Hospital