Evaluation of the Efficacy of Botulinum Toxin Type A in the Treatment of Frontal Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Hyperhidrosis Disease Severity Scale (HDSS) score
研究概览
简要总结
Frontal hyperhidrosis is a form of primary focal hyperhidrosis that significantly impairs patients' quality of life due to excessive visible sweating in the forehead region. Conventional treatment options often show limited efficacy or may be associated with undesirable side effects.
This study aims to evaluate the efficacy and safety of intradermal injections of Botulinum Toxin Type A in patients with primary frontal hyperhidrosis. Clinical outcomes will be assessed using Minor's iodine-starch test, the Hyperhidrosis Disease Severity Scale (HDSS), and patient satisfaction scores. Participants will be followed up one month after treatment to evaluate therapeutic response and potential adverse effects.
详细描述
Primary focal hyperhidrosis is a chronic dermatological disorder characterized by excessive sweating due to overactivity of eccrine sweat glands. Frontal hyperhidrosis is a less common subtype; however, it has a significant psychological and social impact due to the visibility of symptoms and its effect on daily activities and quality of life.
Treatment options include topical antiperspirants such as aluminum chloride, systemic anticholinergic agents such as oxybutynin, and surgical sympathectomy. However, these modalities may be limited by insufficient efficacy or undesirable adverse effects, particularly in frontal hyperhidrosis.
Botulinum toxin type A is a neurotoxin produced by Clostridium botulinum that inhibits the release of acetylcholine at the neuromuscular and neuroglandular junctions, resulting in temporary suppression of eccrine sweat gland activity. Although it is widely used in axillary hyperhidrosis, evidence regarding its use in frontal hyperhidrosis remains limited.
Study Design and Procedures:
This is a prospective interventional clinical study conducted on patients diagnosed with primary frontal hyperhidrosis attending the dermatology clinic at Latakia University Hospital. Written informed consent will be obtained from all participants prior to enrollment.
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
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 40 years.
- •Clinically and objectively confirmed primary focal frontal hyperhidrosis, defined by sweat production >50 mg/min and a Hyperhidrosis Disease Severity Scale (HDSS) score ≥3 (moderate to severe).
- •Inadequate response to topical antiperspirant therapy.
- •No prior treatment with Botulinum toxin type A within the last 6 months.
- •No use of any other hyperhidrosis treatment within the last 3 months.
排除标准
- •Secondary hyperhidrosis due to systemic conditions such as hyperthyroidism, diabetes mellitus, or neurological disorders.
- •Neuromuscular disorders including myasthenia gravis or Lambert-Eaton syndrome. Active dermatological conditions or anatomical abnormalities in the frontal region (e.g., infections, inflammation, scars).
- •Known hypersensitivity to Botulinum toxin or any of its components. Pregnancy or breastfeeding. Use of medications that may interfere with Botulinum toxin activity (e.g., aminoglycosides) within one month prior to treatment.
研究组 & 干预措施
Botulinum Toxin Type A Group
Participants with primary frontal hyperhidrosis will receive intradermal injections of botulinum toxin type A in the affected frontal area. Injection sites will be identified using Minor's iodine-starch test, followed by standardized grid-based mapping to ensure precise localization and uniform distribution of the toxin across the hyperhidrotic region.
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Change in Hyperhidrosis Disease Severity Scale (HDSS) score
时间窗: Baseline and 1 month (4 weeks) after treatment
Assessment of the change in severity of frontal hyperhidrosis using the Hyperhidrosis Disease Severity Scale (HDSS), a 4-point patient-reported scale. The score will be recorded at baseline prior to treatment and compared to the post-treatment score following intradermal Botulinum toxin type A injection. A reduction in score indicates clinical improvement in disease severity
Change in hyperhidrotic area assessed by Minor's iodine-starch test
时间窗: Baseline and 1 month (4 weeks) after treatment
Assessment of changes in the frontal hyperhidrotic area using Minor's iodine-starch test. The affected area will be evaluated at baseline prior to treatment and compared with the post-treatment area following intradermal injection of botulinum toxin type A. Reduction in the stained area indicates decreased eccrine sweat gland activity
次要结局
- Patient satisfaction with clinical outcomes of intradermal botulinum toxin type A treatment in primary frontal hyperhidrosis(1 month (4 weeks) after treatment)
- Incidence of adverse effects following Botulinum toxin type A injections(Within 1 month (4 weeks) after treatment)
研究者
Nabih Raslan, Dr
Principal Investigator
Tishreen University