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

A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03760198

Enrollment

220

Registered

2018-11-30

Start date

2018-08-03

Completion date

2019-09-17

Last updated

2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperhidrosis Primary Focal Axilla

Brief summary

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

Interventions

DRUGMeditoxin

50U of MEDITOXIN is injected intradermally to each axilla

OTHERPlacebo

normal saline is injected intradermally to each axilla

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026