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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

359 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glabellar Frown Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Botulinum Toxin 30 units

I.M. injection

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

Botulinum Toxin 45 units

I.M. injection

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

Botulinum Toxin 60 units

I.M. injection

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

Placebo

I.M. injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Botulinum Toxin Type A

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No