Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis

Medytox

Status and phase: Completed; Phase 3

Conditions: Hyperhidrosis Primary Focal Axilla

Treatments: Drug: Meditoxin; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03760198

MT01-KR17PAH311

Details and patient eligibility

About

This study is intented to evaluate the efficacy and safety of MEDITOXIN compared to placebo in treatment of primary axillary hyperhidrosis.

Enrollment: 220 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients aged from 20 to 65, with persistent bilateral primary axillary hyperhidrosis

Exclusion criteria

• those who have secondary hyperhidrosis
• those who have systemic neuromuscular junction disorders
• women who are pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

botulinum toxin type A

Experimental group

Treatment:

Drug: Meditoxin

Placebo

Placebo Comparator group

Treatment:

Other: Placebo