NCT00515944

Brief Summary

Xeomin® is a Botulinum neurotoxin type A preparation free of complexing proteins, i.e. free of bacterial proteins other than the active toxin. Injected into the muscle, Xeomin® causes local weakening. Botulinum toxin type A is used for certain neurological and aesthetic treatments. This study will investigate the migration potential of Xeomin®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1 healthy

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 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 1, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

August 13, 2007

Last Update Submit

March 31, 2009

Conditions

Healthy

Keywords

No conditionhealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Measurement of area

Interventions

Botulinum neurotoxin type A, free of complexing proteinsDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy females, 18 to 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merz Pharmaceuticals GmbH

Frankfurt am Main, 61273, Germany

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 Officials

  • Merz Pharmaceuticals

    Merz Pharmaceuticals GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

April 1, 2009

Record last verified: 2009-03

Locations

DE(1)