Botulinum toxin type A for head/forehead hyperhidrosis

JRCT ID: jRCTs041180084

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head/forehead hyperhidrosis
• Date of first enrollment: 08/09/2017
• Target sample size: 15
• Study type: Interventional
• Intervention(s): At head and forehead, 2 units (0.08ml) of Botulinum toxin type A is injected at 1-1.5cm intervals (Head;20-30 injections, Forehead; 20-30injections, approximately 50 injections in total) to avoid eyelid ptosis Approximately 1 cm away from the eyebrow.

Outcome(s)

Primary Outcome

Responder rate measured by ventilated capsule method and weight measuring method after 6 weeks from the first injections.
The responder is defined as the perspiration amount is reduced by 50% or more as compared with the baseline in any item of the ventilation capsule method or the weight measurement method.

• Secondary Outcome: Responder rate of perspiration at all evaluation points after administration (responder rate measured after 6 weeks from first administration is the main evaluation), mean perspiration weight, rate of change from baseline of perspiration weight, HDSS responder rate (Percentage of subjects whose HDSS score improved by 2 points or more from baseline), The amount of change from the baseline of HDSS, the total score of the score of DLQI, the score of each area of DLQI score, the change of the score of each question of DLQI score from baseline, subject's satisfaction and duration of effect.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

Patients who meet the criteria of primary topical hyperhidrosis for head and forehead.
The Criteria of primary focal hyperhidrosis.
Focal, visible, excessive sweating of at least 6 months duration without apparent cause with at least two of the following characteristics:
1) Age of onset less than 25 years
2) Bilateral and relatively symmetric
3) Cessation of focal sweating during sleep
4) Frequency of at least one episode per week
5) Positive family history
6) Impairs daily activities

Exclude criteria

Patients who have symptom of irritation against component of botulinum toxin type A.
Women who are pregnant or may become pregnant and lactating women.
Patients with systemic neuromuscular junction dysfunction (myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis and others).
Patients who have received treatment with Botulinum toxin type A within 1 year and suspected the presence of neutralizing antibodies.
Patients who are using other types of botulinum toxin and (tubocurarine chloride hydrochloride hydrate, dantrolene sodium hydrate and others).
In case a patient conducts other treatments for hyperhidrosis (external or internal medicine), s/he needs to have a washout period for 1 month.

Related Information

• Primary Sponsor: Ohshima Yuichiro