Brimonidine 0.33% for Rosacea-Related Facial Erythema

NCT07431476 | Completed Phase 4

• 2 other identifiers: SBU-IEAH-DER-BRIM-ROS-01Medipol-EC-502
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Rosacea; Rosacea Subtype 1 (Erythematotelangiectatic)

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; Telangiectasia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Dermoscopy Erythema Intensity Score (DEYS)

  Day 1: 0 hour and 1 hour; and Month 1: 0 hour and 1 hour

• Clinical Erythema Score (0-4 Scale)

  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)

  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

  Baseline and Month 1

• Skindex-16 Dermatology Quality of Life Score

  Baseline and Month 1

Study Arms (2)

Experimental: Brimonidine 0.33% Gel

EXPERIMENTAL

Facial half randomized to receive topical brimonidine tartrate 0.33% gel during the acute split-face phase.

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.

Drug: Placebo gel

Interventions

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.

Experimental: Brimonidine 0.33% Gel

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.

Placebo Comparator: Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital, Department of Dermatology

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 23839181 RESULT

MeSH Terms

Conditions

Rosacea; Depression; Telangiectasis

Interventions

Brimonidine Tartrate; Gels

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: "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.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: February 24, 2026
• Study Start: May 1, 2025
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: February 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)