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

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Drug: Placebo; Drug: Botulinum Toxin Type A

• Registration Number: NCT02236312
• Lead Sponsor: Galderma R&D

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 to very severe glabellar frown lines.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-10
• Primary Completion: 2014-11
• Study Completion: 2015-05
• Status Verified: 2016-05
• Disposition First Submitted: 2016-05-13
• Disposition First Submitted QC: 2016-05-13
• Disposition First Posted: 2016-06-02
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	I.M. injection
Botulinum Toxin 30 units	Botulinum Toxin Type A	I.M. injection
Botulinum Toxin 45 units	Botulinum Toxin Type A	I.M. injection
Botulinum Toxin 60 units	Botulinum Toxin Type A	I.M. injection

Primary Outcome Measures

Name	Time	Method
Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin	14 Days	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.

Trial Locations

Locations (1)

Private practice; 🇺🇸 Salt Lake City, Utah, United States