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

Phase 3

Completed

• Conditions: Hyperhidrosis Primary Focal Axilla
• Interventions: Drug: Meditoxin; Other: Placebo

• Registration Number: NCT03760198
• Lead Sponsor: Medy-Tox

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-03
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Primary Completion: 2019-07-03
• Study Completion: 2019-09-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin type A	Meditoxin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
the proportion of treatment responder	4 weeks after the injection	subjects who reported at least a 2-point improvement from baseline HDSS score

Trial Locations

Locations (1)

Catholic University St. Paul Hospital; 🇰🇷 Seoul, Dongdaemun-gu, Korea, Republic of