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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03960957
Other study ID # 43USD1805
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 17, 2019
Est. completion date April 16, 2020

Study information

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

Clinical Trial Summary

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date April 16, 2020
Est. primary completion date September 27, 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 - Understands the study requirements and signs an informed consent form Exclusion Criteria: - Botulinum toxin treatment in the face within 6 months prior to study treatment

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AbobotulinumtoxinA
Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
Other:
Placebo
Treatment of glabellar facial lines with placebo

Locations

Country Name City State
United States Galderma Study Site Atlanta Georgia
United States Galderma Study Site Austin Texas
United States Galderma Study Site Cincinnati Ohio
United States Galderma Study Site Coral Gables Florida
United States Galderma Study Site Omaha Nebraska
United States Galderma Study Site Redondo Beach California
United States Galderma Study Site Saint Louis Missouri
United States Galderma Study Site San Diego California
United States Galderma Study Site Spring Texas
United States Galderma Study Site Washington District of Columbia
United States Galderma Study Site Westport Connecticut

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 Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) Month 1 after treatment
See also
  Status Clinical Trial Phase
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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 NCT03736928 - Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines Phase 2
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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