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Botulinum Toxin Type A for Frontal Hyperhidrosis

24 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Hyperhidrosis Disease Severity Scale (HDSS) score
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient satisfaction with clinical outcomes of intradermal botulinum toxin type A treatment in primary frontal hyperhidrosis
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 novembre 2025

Achèvement primaire (Estimé)

30 juillet 2026

Achèvement de l'étude (Estimé)

20 novembre 2026

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

24 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Primary Frontal Hyperhidrosis

Essais cliniques sur Botulinum Toxin Type A

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