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MT10107 vs Botox for Glabella Lines
NCT03908008Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2014
- Primary completion
- May 2014
- Sponsor
- Medytox Inc.
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- glabellar lines
01
Overview
Phase 3, randomised, double-blind trial of botulinum toxin type A in glabellar lines (2 arms), sponsored by Medytox Inc. Primary endpoint: Investigator's live assessment of glabella line improvement rate at 4 weeks. Started Jan 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
MT10107
20U of MT10107 (Coretox) injected into 5 sites of the glabella line.
Botox
20U of Botox (onabotulinumtoxinA) injected into 5 sites of the glabella line.
03
Who it enrols
Adults aged 20-65 with moderate to severe glabellar frown lines (grade 2 or higher). Excludes patients with neuromuscular disorders, bleeding tendencies, recent botulinum toxin injections (within 3 months), or use of muscle relaxants/antibiotics within 4 weeks.
04
Endpoints
Primary
Investigator's live assessment of glabella line improvement rate
Secondary
Investigator's live assessment of glabella line improvement rate
Investigator's photographic assessment of glabella line improvement rate at maximum frown
Investigator's photographic assessment of glabella line improvement rate at rest
Subject's satisfaction questionnaire to assess treatment efficacy
Glabella line improvement rate of subject's assessment
The number of participants with adverse events
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