Botulinum toxin A injections for excessive forehead sweating
Evaluation of the Efficacy of Botulinum Toxin Type A in the Treatment of Frontal Hyperhidrosis
This will test whether injections of botulinum toxin type A can reduce excessive forehead sweating in adults with primary frontal hyperhidrosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Tishreen University Academic / other |
| Locations | 1 site (Latakia) |
| Trial ID | NCT07561580 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional study at Latakia University Hospital testing intradermal botulinum toxin type A injections in patients with primary frontal hyperhidrosis. Eligibility requires age 18–40, objective sweat production >50 mg/min and an HDSS score of 3 or higher, with prior inadequate response to topical antiperspirants. Outcomes include Minor's iodine-starch test, the Hyperhidrosis Disease Severity Scale (HDSS), and patient satisfaction, with safety and efficacy checked one month after treatment. Patients with secondary causes of hyperhidrosis, neuromuscular disorders, pregnancy, known hypersensitivity, or active frontal skin infections are excluded.
Who should consider this trial
Good fit: Adults 18–40 with clinically and objectively confirmed primary frontal hyperhidrosis (sweat >50 mg/min and HDSS ≥3) who failed topical antiperspirants and have not received botulinum toxin in the past 6 months.
Not a fit: Patients with secondary hyperhidrosis, neuromuscular disorders, pregnancy or breastfeeding, known allergy to botulinum toxin, active frontal skin infections, or those outside the age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this treatment could temporarily reduce visible forehead sweating and improve daily comfort and social confidence.
How similar studies have performed: Botulinum toxin type A is well established and effective for axillary hyperhidrosis, but its use specifically for frontal hyperhidrosis is less well studied and has limited published evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Latakia
- Latakia University Hospital — Latakia, Syria (Recruiting)
Study contacts
- Principal investigator: Zeinab Y Mohammad, MD — Latakia University
- Study coordinator: Zeinab Y Mohammad, MD
- Email: zeinab.y.mohammad@latakia-univ.edu.sy
- Phone: +963937109668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.