Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

Study Overview
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Brief Summary
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Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles. One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.

Detailed Description
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There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways electrophysiologically and clinically and results obtained with one formulation cannot be extrapolated to the other. There are only few clinical research directly comparing the two formulations in the treatment of forehead lines.

Official Title
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Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection

Conditions
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Wrinkles

Intervention / Treatment
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* Drug: Botulinum Toxin Type A - Azzalure
* Drug: Botulinum Toxin Type A - Vistabel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Subjects of any race, from 18 to 65 years old Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential Exclusion Criteria: Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than: Retinoid, microdermabrasion, or prescription level glycolic acid treatments 2 weeks Non-ablative light treatments (e.g. Intense Pulsed Light, light-emitting diodes) 1 month Ablative skin resurfacing Non-ablative dermal treatment for skin tightening (e.g. radio-frequency treatments) 6 months Treatment with a BoNT-A 12 months Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic acid preparations) 24 months Subjects who undergone a surgical facelift; Permanent or semi-permanent dermal fillers in the forehead area; Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts); Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics; Pregnant women, nursing mothers, or women who are planning pregnancy during the study;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intra-individual comparison<br> | Drug: Botulinum Toxin Type A - Azzalure<br>* One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.<br>Drug: Botulinum Toxin Type A - Vistabel<br>* One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead | Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side. | 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forehead Wrinkles Toxin