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NCT03736928 Clinical Trial

Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Glabellar Frown Lines Clinical Trial

Official title:
A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03736928
Other study ID # 43USD1801
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 26, 2018
Est. completion date August 20, 2020

Study information
Verified date January 2021
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines

Recruitment information / eligibility
Status Completed
Enrollment 401
Est. completion date August 20, 2020
Est. primary completion date December 9, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale - Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale Exclusion Criteria: - Botulinum toxin treatment in the face within 9 months prior to study treatment

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• AbobotulinumtoxinA dose level 1 or 2
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Other:
• placebo
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Biological:
• AbobotulinumtoxinA dose 3
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
• AbobotulinumtoxinA dose 4
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines

Locations
Country Name City State
United States Galderma Research Site Chapel Hill North Carolina
United States Galderma Research Site Charlotte North Carolina
United States Galderma Research Site Chicago Illinois
United States Galderma Research Site Coral Gables Florida
United States Galderma Research Site Encino California
United States Galderma Research Site Manhattan Beach California
United States Galderma Research Site Mequon Wisconsin
United States Galderma Research Site New Orleans Louisiana
United States Galderma Research Site New York New York
United States Galderma Research Site Vista California

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Composite Responders at Month 1 composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) Month 1 after treatment
See also
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Active, not recruiting NCT05565950 - AI-09 In Subjects With Glabellar Lines, GL-101 Phase 1/Phase 2
Completed NCT00430963 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines Phase 3
Recruiting NCT05083286 - Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines Early Phase 1
Completed NCT03687736 - Subject Satisfaction With AbobutulinumtoxinA Treatment Phase 4
Active, not recruiting NCT04281745 - Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX® Phase 4
Active, not recruiting NCT05623410 - Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines Phase 3
Active, not recruiting NCT03440671 - The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 3
Completed NCT01808742 - Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device N/A
Completed NCT00777803 - NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines Phase 3
Completed NCT00430586 - Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines Phase 2
Completed NCT04281095 - A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines Phase 1/Phase 2
Active, not recruiting NCT05146999 - Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT02428608 - Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 Phase 2
Completed NCT04143815 - Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines Phase 2
Not yet recruiting NCT05305768 - Xeomin Treatment of Glabellar Lines Using OLD Versus COLD Early Phase 1
Completed NCT05364580 - The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT05320393 - Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines Phase 2
Completed NCT02677805 - Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II Phase 3
Not yet recruiting NCT05894109 - Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids N/A