Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris: A Comparative Study With Intense Pulsed Light (IPL)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Post-Inflammatory Erythema Severity Score measured by Clinician Erythema Assessment (CEA) Scale 0-4
研究概览
简要总结
Post-inflammatory erythema (PIE) is a common sequela of acne vulgaris, characterized by persistent erythematous macules resulting from superficial vascular dilation. Current treatment options include energy-based devices such as intense pulsed light (IPL); however, these modalities may be costly and require specialized equipment.
Timolol, a non-selective beta-adrenergic receptor blocker, has demonstrated vasoconstrictive properties and has been used off-label in dermatology for vascular-related conditions. This study aims to evaluate the efficacy and safety of topical 0.5% timolol ophthalmic solution in improving post-inflammatory erythema secondary to acne vulgaris and to compare its clinical outcomes with those achieved by intense pulsed light (IPL) therapy.
This prospective comparative study will assess changes in erythema severity using standardized clinical evaluation and objective measurement tools over a defined treatment period. The findings may provide evidence for a cost-effective and accessible therapeutic alternative for managing post-acne erythema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Age ≥ 12 years with a history of acne vulgaris.
- •Clinically diagnosed with post-inflammatory erythema (PIE) secondary to acne vulgaris.
- •Willing and able to provide informed consent (or assent with parental/guardian consent if under 18 years of age).
排除标准
- •Refusal to participate or inability to comply with study procedures (examinations, treatment, follow-up visits), or loss to follow-up.
- •Presence of post-inflammatory hyperpigmentation (PIH) at the study site that may interfere with accurate assessment of erythema.
- •Presence of other dermatologic conditions affecting the treatment area (e.g., atopic dermatitis, rosacea, lupus erythematosus).
- •Known hypersensitivity or adverse reaction to timolol or other beta-adrenergic receptor blockers.
- •Pregnant or breastfeeding women.
- •History of cardiovascular or respiratory conditions contraindicating beta-blocker use (e.g., asthma, atrioventricular block, bradycardia <50 beats per minute, hypotension).
- •Use of other topical medications or cosmetic products (except sunscreen) on the study area during the study period.
研究组 & 干预措施
Topical Timolol 0.5%
干预措施: Timolol 0.5% Ophthalmic Solution (Drug)
Intense Pulsed Light (IPL)
干预措施: Intense Pulsed Light (Device)
结局指标
主要结局
Change in Post-Inflammatory Erythema Severity Score measured by Clinician Erythema Assessment (CEA) Scale 0-4
时间窗: Baseline, Day 14 and Day 28
Post-inflammatory erythema severity will be assessed using the Clinician Erythema Assessment (CEA) scale ranging from 0 (clear) to 4 (severe erythema). Higher scores indicate more severe erythema.
Number of Post Inflammatory Erythema lesions
时间窗: Baseline, Day 14 and Day 28
The number of facial post-inflammatory erythema lesions will be counted by a dermatologist during clinical examination.
次要结局
- Number of participants with local adverse events(Baseline to Day 28)
- Number of participants with systemic adverse events(Baseline to Day 28)
- Patient aesthetic satisfaction score measured by Visual Analog Scale (VAS)(Day 28)