Effectiveness of Intradermal Microbotulinum Toxin for the Treatment of Seborrhea and Enlarged Facial Pores: A Prospective Before-and-After Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in sebum production (mm²) from baseline to 6 weeks after intradermal botulinum toxin type A treatment
研究概览
简要总结
This study aims to evaluate the efficacy and safety of microdoses of botulinum toxin type A (microtoxin) for improving periocular skin quality and reducing fine wrinkles. Botulinum toxin is commonly used in aesthetic medicine; however, its use in microdoses has been proposed to achieve more natural results with fewer adverse effects.
Participants with periocular rhytids will receive intradermal injections of diluted botulinum toxin. Clinical outcomes will include improvement in skin texture, wrinkle reduction, and patient satisfaction. Safety will be assessed by monitoring adverse events.
The findings of this study may help determine whether microtoxin is an effective and safe option for minimally invasive periocular rejuvenation.
详细描述
This prospective interventional study aims to assess the efficacy and safety of intradermal microdoses of botulinum toxin type A (microtoxin) for the treatment of periocular rhytids. The microtoxin technique involves the administration of highly diluted botulinum toxin in small aliquots injected superficially into the dermis, targeting fine wrinkles and improving overall skin quality without significantly affecting muscle function.
Participants presenting with periocular dynamic and static rhytids will undergo treatment with standardized microtoxin injections. Clinical evaluation will be performed using validated aesthetic scales, photographic documentation, and patient-reported outcomes. The primary outcome measure will be the degree of wrinkle reduction and improvement in skin texture. Secondary outcomes will include patient satisfaction and incidence of adverse events.
Follow-up assessments will be conducted over a defined period to evaluate both efficacy and safety. This study seeks to provide evidence regarding the clinical utility of microtoxin in periocular rejuvenation and to support its use as a minimally invasive alternative to conventional botulinum toxin techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study with no masking. All participants and investigators are aware of the intervention administered.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 35 years
- •Both male and female participants
- •Presence of mild to moderate periocular fine wrinkles
- •Willingness to undergo intradermal botulinum toxin injections
- •Ability to provide written informed consent
排除标准
- •Previous botulinum toxin treatment in the periocular area within the last 6 months
- •Known hypersensitivity to botulinum toxin or its components
- •Active skin infection or dermatologic disease in the treatment area
- •Neuromuscular disorders
- •Pregnancy or breastfeeding
- •Use of medications affecting neuromuscular transmission
- •History of eyelid or periocular surgery within the last 6 months
研究组 & 干预措施
Microtoxin Treatment
Participants receive intradermal microdoses of botulinum toxin type A (microtoxin) administered in the periocular region for the treatment of fine wrinkles and improvement of skin quality. The intervention consists of diluted botulinum toxin injected superficially using a standardized technique.
干预措施: Botulinum Toxin Type A (Dysport®) (Drug)
结局指标
主要结局
Change in sebum production (mm²) from baseline to 6 weeks after intradermal botulinum toxin type A treatment
时间窗: Baseline and 6 weeks after treatment
The primary outcome is the change in sebum production from baseline to 6 weeks after treatment. Sebum production will be measured using oil-absorbing sheets and quantified as the transparent area in mm² under standardized conditions.
次要结局
- Change in patient-reported satisfaction with periocular appearance using FACE-Q(Baseline and 4 weeks after treatment)