Botulinum Toxin Type A for Frontal Hyperhidrosis

Официальное название

Evaluation of the Efficacy of Botulinum Toxin Type A in the Treatment of Frontal Hyperhidrosis

Обзор

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.

Подробное описание

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.

A detailed medical history will be obtained to exclude patients with neuromuscular disorders, hypersensitivity to botulinum toxin or its components, and active local skin infections.

Baseline assessment of disease severity will be performed using the Hyperhidrosis Disease Severity Scale (HDSS).

The affected frontal area will be identified using Minor's iodine-starch test to confirm active sweating zones. The area will then be mapped into a grid of approximately 2.25 cm² squares with 1 cm spacing between injection points.

Botulinum toxin type A will be reconstituted with 5 ml of 0.9% sodium chloride solution to achieve a concentration of 20 units/ml. Intradermal injections of 2 units per grid point will be administered using a 30-gauge insulin needle.

The total dose will range between 40-80 units depending on the extent of the affected area.

Follow-up evaluation will be performed one month (4 weeks) after treatment.

Clinical outcomes will be assessed using:

* Hyperhidrosis Disease Severity Scale (HDSS) * Minor's iodine-starch test for assessment of sweating area reduction * Patient satisfaction questionnaire using a 5-point Likert scale * Recording of any adverse effects or complications

Outcome measures will include reduction in sweating area, improvement in HDSS score, patient-reported satisfaction, and incidence of adverse events.

Вмешательства

• Препарат Botulinum Toxin Type A
  Botulinum toxin type A will be reconstituted with 5 mL of 0.9% sodium chloride solution to achieve a concentration of 20 units/mL. Intradermal injections of 2 units per injection point will be administered using a 30-gauge insulin needle. The affected frontal area will be mapped using Minor's iodine-starch test and divided into a grid of approximately 2.25 cm² squares with 1 cm spacing between injection points. The total dose will range from 40 to 80 units depending on the extent of the affected

Первичные конечные точки

• Change in Hyperhidrosis Disease Severity Scale (HDSS) score [Срок оценки: Baseline and 1 month (4 weeks) after treatment]
• Change in hyperhidrotic area assessed by Minor's iodine-starch test [Срок оценки: Baseline and 1 month (4 weeks) after treatment]

Вторичные конечные точки (2)

• Patient satisfaction with clinical outcomes of intradermal botulinum toxin type A treatment in primary frontal hyperhidrosis [Срок оценки: 1 month (4 weeks) after treatment]
• Incidence of adverse effects following Botulinum toxin type A injections [Срок оценки: Within 1 month (4 weeks) after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Syria · 1 центр

• Latakia University Hospital — Latakia

Публикации

• Campanati A, et al. Treatment of Forehead Hyperhidrosis with Incobotulinum Toxin Type A. Clin Cosmet Investig Dermatol. 2022;15:1-4.
• Boger A, Herath H, Rompel R, Ferbert A. Botulinum toxin for treatment of craniofacial hyperhidrosis. J Neurol. 2000 Nov;247(11):857-61. doi: 10.1007/s004150070073. PMID 11151418
• Lowe NJ, et al. Treatment of hyperhidrosis with botulinum toxin type A. J Clin Aesthet Dermatol. 2023;16(3):20-25.
• Glaser DA, Hebert AA, Pariser DM, Solish N. Interventions for hyperhidrosis in secondary care. Cochrane Database Syst Rev. 2016;CD010036.
• Grabell DA, Hebert AA. Hyperhidrosis: current management. Clin Cosmet Investig Dermatol. 2017;10:829-833.

Идентификаторы

NCT: NCT07561580 · FH-BTXA-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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