NCT07431476

Brimonidine 0.33% for Rosacea-Related Facial Erythema

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Istanbul Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Rosacea
• Rosacea Subtype 1 (Erythematotelangiectatic)

Interventions

Type	Name	Description
DRUG	Brimonidine 0.33% 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.
DRUG	Placebo gel	Vehicle gel identical in appearance and texture to the active formulation, applied to the contralateral facial half during the acute split-face phase only.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-07
• Completion: 2025-08-07
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Turkey (Türkiye)