NCT03760198

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

November 29, 2018

Last Update Submit

July 27, 2020

Conditions

Hyperhidrosis Primary Focal Axilla

Outcome Measures

Primary Outcomes (1)

  • the proportion of treatment responder

    subjects who reported at least a 2-point improvement from baseline HDSS score

    4 weeks after the injection

Study Arms (2)

botulinum toxin type A

EXPERIMENTAL
Drug: Meditoxin

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

MeditoxinDRUG

50U of MEDITOXIN is injected intradermally to each axilla

botulinum toxin type A
PlaceboOTHER

normal saline is injected intradermally to each axilla

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University St. Paul Hospital

Seoul, Dongdaemun-gu, 130-709, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2018

First Posted

November 30, 2018

Study Start

August 3, 2018

Primary Completion

July 3, 2019

Study Completion

September 17, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

KR(1)