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Botulinum Toxin Type A for Frontal Hyperhidrosis

24 april 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Hyperhidrosis Disease Severity Scale (HDSS) score
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient satisfaction with clinical outcomes of intradermal botulinum toxin type A treatment in primary frontal hyperhidrosis
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Zeinab Y Mohammad, MD, Latakia university

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • 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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 november 2025

Primaire voltooiing (Geschat)

30 juli 2026

Studie voltooiing (Geschat)

20 november 2026

Studieregistratiedata

Eerst ingediend

24 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

24 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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