Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

NCT01485601 | Completed Phase 2 Results DMC

• 1 other identifier: MT-GPRT-GL01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.

  Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).

  at Day 30

Study Arms (2)

MT10109

EXPERIMENTAL

Clostridium botulinum toxin type A

Biological: MT10109

Botox (registered trade mark)

ACTIVE COMPARATOR

Clostridium botulinum toxin type A

Biological: MT10109

Interventions

MT10109 BIOLOGICAL

Single dose intramuscular injection MT10109 vs Botox®

Botox (registered trade mark); MT10109

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
• Women of childbearing potential must have a negative serum pregnancy test at screening

You may not qualify if:

• Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
• Patients with an anaphylactic response history to botulinum toxin type A.
• Patients who have been administered botulinum toxin type A within the previous 6 months.
• Pregnant or lactating women.
• Participation in any research study involving drug administration within 90 days preceding enrollment.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Unknown Facility

Melbourne, Australia

Location

Results Point of Contact

• Title: Young Ryu
• Organization: Medytox Inc.

young.ryu@medytox.com

+82-2-6901-5890

Study Officials

• Peter Foley, Doctor

  Austrailia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: December 1, 2011
• First Posted: December 5, 2011
• Study Start: December 7, 2011
• Primary Completion: March 30, 2012
• Study Completion: August 17, 2012
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2023-07

Locations

AU (1)