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

Galderma

Status and phase: Completed; Phase 2

Conditions: Glabellar Frown Lines

Treatments: Drug: Botulinum Toxin Type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02236312

43QM1313

Details and patient eligibility

About

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.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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359 participants in 4 patient groups, including a placebo group

Botulinum Toxin 30 units

Experimental group

Description:

I.M. injection

Treatment:

Drug: Botulinum Toxin Type A

Botulinum Toxin 45 units

Experimental group

Description:

I.M. injection

Treatment:

Drug: Botulinum Toxin Type A

Botulinum Toxin 60 units

Experimental group

Description:

I.M. injection

Treatment:

Drug: Botulinum Toxin Type A

Placebo

Placebo Comparator group

Description:

I.M. injection

Treatment:

Drug: Placebo