Botulinum Toxin Type A for Frontal Hyperhidrosis

NCT07561580 | Recruiting

• 1 other identifier: FH-BTXA-2026-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Frontal Hyperhidrosis

Keywords

Frontal hyperhidrosis, Primary focal hyperhidrosis, Botulinum toxin type A, Intradermal injection, HDSS, Minor's starch iodine test.

Outcome Measures

Primary Outcomes (2)

• Change in Hyperhidrosis Disease Severity Scale (HDSS) score

  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

  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

Secondary Outcomes (2)

• Patient satisfaction with clinical outcomes of intradermal botulinum toxin type A treatment in primary frontal hyperhidrosis

  1 month (4 weeks) after treatment

• Incidence of adverse effects following Botulinum toxin type A injections

  Within 1 month (4 weeks) after treatment

Study Arms (1)

Botulinum Toxin Type A Group

EXPERIMENTAL

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.

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

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.

Botulinum Toxin Type A Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Latakia University Hospital

Latakia, Syria

RECRUITING

Related Publications (5)

• Campanati A, et al. Treatment of Forehead Hyperhidrosis with Incobotulinum Toxin Type A. Clin Cosmet Investig Dermatol. 2022;15:1-4.

  BACKGROUND

• Böger A, et al. Botulinum toxin for treatment of craniofacial hyperhidrosis. J Neurol. 2000;247(11):857-861.

  BACKGROUND

• Lowe NJ, et al. Treatment of hyperhidrosis with botulinum toxin type A. J Clin Aesthet Dermatol. 2023;16(3):20-25.

  BACKGROUND

• Glaser DA, Hebert AA, Pariser DM, Solish N. Interventions for hyperhidrosis in secondary care. Cochrane Database Syst Rev. 2016;CD010036.

  BACKGROUND

• Grabell DA, Hebert AA. Hyperhidrosis: current management. Clin Cosmet Investig Dermatol. 2017;10:829-833.

  BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Zeinab Y Mohammad, MD

  Latakia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeinab Y Mohammad, MD

CONTACT

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

Mohamad A Ismaiel, MD, PhD

CONTACT

‪+963933471500‬; mohamad.ismaiel@latakia-univ.edu.sy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)