Botulinum Toxin Type A for Frontal Hyperhidrosis
ConditionPrimary Frontal Hyperhidrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorTishreen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 40 years.
Disqualifiers
Secondary hyperhidrosis due to systemic conditions such as hyperthyroidism, diabetes mellitus, or neurological disorders.
Trial design
Design model
Single group
Treatments tested in this trial
Botulinum Toxin Type A
DrugBotulinum 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Botulinum Toxin Type A GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and 1 month (4 weeks) after treatment2
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
Time frame
Baseline and 1 month (4 weeks) after treatmentSecondary outcomes
1
Patient satisfaction with clinical outcomes of intradermal botulinum toxin type A treatment in primary frontal hyperhidrosis
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
Time frame
1 month (4 weeks) after treatment2
Incidence of adverse effects following Botulinum toxin type A injections
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
Time frame
Within 1 month (4 weeks) after treatmentSponsors and contacts
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Source ClinicalTrials.gov