Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines

Glabellar Frown Lines Clinical Trial

Official title:

A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236312
• Other study ID #: 43QM1313
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest

Exclusion Criteria:

• Any previous treatment with any botulinum toxin

• Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart

• Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region

• Any history of facial surgery above the lower orbital rim

• Any planned facial surgery or aesthetic procedure during the study period

• Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• Botulinum Toxin Type A

• Placebo

Locations

Country	Name	City	State
United States	Private practice	Aventura	Florida
United States	Private practice	Birmingham	Alabama
United States	Private practice	Englewood	Colorado
United States	Private practice	Mobile	Alabama
United States	Private practice	Nashville	Tennessee
United States	Private practice	Salt Lake City	Utah
United States	Private practice	San Antonio	Texas
United States	Private practice	San Diego	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	Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin	Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.	14 Days