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Botulinum Toxin Type A for Frontal Hyperhidrosis

24 de abril de 2026 atualizado por: Nabih Raslan, Dr, Tishreen University

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

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.

Visão geral do estudo

Status

Recrutamento

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
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 area.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Hyperhidrosis Disease Severity Scale (HDSS) score
Prazo: 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
Baseline and 1 month (4 weeks) after treatment
Change in hyperhidrotic area assessed by Minor's iodine-starch test
Prazo: 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
Baseline and 1 month (4 weeks) after treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patient satisfaction with clinical outcomes of intradermal botulinum toxin type A treatment in primary frontal hyperhidrosis
Prazo: 1 month (4 weeks) after treatment
Satisfaction will be assessed using a 5-point Likert scale ranging from very dissatisfied to very satisfied following intradermal botulinum toxin type A injections. Higher scores indicate greater satisfaction and improved perceived symptom control
1 month (4 weeks) after treatment
Incidence of adverse effects following Botulinum toxin type A injections
Prazo: Within 1 month (4 weeks) after treatment
Assessment of local and systemic adverse effects following intradermal Botulinum toxin type A injections. Reported complications may include brow ptosis, upper eyelid ptosis, pain at injection site, bruising, headache, and transient weakness. Adverse events will be recorded and classified as present or absent during the 4-week follow-up period
Within 1 month (4 weeks) after treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Zeinab Y Mohammad, MD, Latakia university

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

  • Campanati A, et al. Treatment of Forehead Hyperhidrosis with Incobotulinum Toxin Type A. Clin Cosmet Investig Dermatol. 2022;15:1-4.
  • Böger A, et al. Botulinum toxin for treatment of craniofacial hyperhidrosis. J Neurol. 2000;247(11):857-861.
  • 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.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de novembro de 2025

Conclusão Primária (Estimado)

30 de julho de 2026

Conclusão do estudo (Estimado)

20 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

24 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de abril de 2026

Primeira postagem (Real)

1 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Primary Frontal Hyperhidrosis

Ensaios clínicos em Botulinum Toxin Type A

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