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| ID | Type | Description | Link |
|---|---|---|---|
| Medipol-EC-502 | Other Identifier | Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Brimonidine 0.33% Gel | Experimental | Facial half randomized to receive topical brimonidine tartrate 0.33% gel during the acute split-face phase. |
|
| Placebo Comparator: Vehicle Gel | Placebo Comparator | Contralateral facial half randomized to receive vehicle gel during the acute split-face phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine 0.33% gel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (0 hour), 1 hour, and 3 hours on Day 1; and 0 hour and 1 hour at the 1-month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Dermoscopy Erythema Intensity Score (DEYS) | Semi-quantitative dermoscopic score evaluating erythema intensity on a predefined 0-4 scale. Higher scores indicate greater erythema intensity. | Day 1: 0 hour and 1 hour; and Month 1: 0 hour and 1 hour |
| Clinical Erythema Score (0-4 Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Training and Research Hospital, Department of Dermatology | Istanbul | 34098 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23839181 | Result | 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. |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D003863 | Depression |
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D005782 | Gels |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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"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.
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In this split-face study, the allocation of brimonidine gel and placebo gel to the left or right facial side was randomized and concealed. Participants were not informed which side received the active treatment. Care providers applying the products were masked by the use of identical, unlabeled syringes prepared by an independent coordinator. Outcome assessors evaluating erythema measurements and dermoscopic images were also masked to treatment allocation.
| Placebo gel | Drug | Vehicle gel identical in appearance and texture to the active formulation, applied to the contralateral facial half during the acute split-face phase only. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour) |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |