Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

1. Female Subjects of any race, from 18 to 65 years old

2. Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead

3. Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential

Exclusion Criteria:

1. 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

2. Subjects who undergone a surgical facelift;

3. Permanent or semi-permanent dermal fillers in the forehead area;

4. Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts);

5. Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics;

6. Pregnant women, nursing mothers, or women who are planning pregnancy during the study;