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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Erythema Index (EI) measured with Mexameter (MX18)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Experimental: Brimonidine 0.33% Gel
Facial half randomized to receive topical brimonidine tartrate 0.33% gel during the acute split-face phase.
干预措施: Brimonidine 0.33% gel (Drug)
Placebo Comparator: Vehicle Gel
Contralateral facial half randomized to receive vehicle gel during the acute split-face phase.
干预措施: Placebo gel (Drug)
结局指标
主要结局
Change in Erythema Index (EI) measured with Mexameter (MX18)
时间窗: 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.
次要结局
- 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)
- Dermoscopy Vessel Density Area Score (DDYAS)(Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour))
- Average Vessel Thickness Score (ODKS)(Day 1 (0 hour, 1 hour); Month 1 (0 hour, 1 hour))
研究者
Yavuz Selim Pilis
Principal Investigator
Istanbul Training and Research Hospital