Botulinum Toxin Type A for Frontal Hyperhidrosis
Evaluation of the Efficacy of Botulinum Toxin Type A in the Treatment of Frontal Hyperhidrosis
Tishreen University
30 participants
Nov 20, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- 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.
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Interventions
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.
Locations(1)
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NCT07561580