Status:

COMPLETED

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

Lead Sponsor:

Galderma R&D

Conditions:

Glabellar Frown Lines

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2015

Estimated Enrollment :

359 Patients enrolled

Trial Details

Trial ID

NCT02236312

Start Date

September 1 2014

End Date

May 1 2015

Last Update

August 26 2022

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Private practice

Birmingham, Alabama, United States

2

Private practice

Mobile, Alabama, United States

3

Private practice

San Diego, California, United States

4

Private practice

Englewood, Colorado, United States