RecruitingNot Applicable

Botulinum Toxin Type A for Frontal Hyperhidrosis

Syria30 participantsStarted 2025-11-20

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Hyperhidrosis Disease Severity Scale (HDSS) score

Timeframe: Baseline and 1 month (4 weeks) after treatment

Change in hyperhidrotic area assessed by Minor's iodine-starch test

Timeframe: Baseline and 1 month (4 weeks) after treatment

Trial details

NCT IDNCT07561580

SponsorTishreen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Zeinab Y Mohammad, MD

+963937109668 zeinab.y.mohammad@latakia-univ.edu.sy