Phase 2 N=30 Randomized Single-blind Treatment

Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

Wrinkles

Bottom Line

View on ClinicalTrials.gov: NCT01014871 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2012

Primary outcome: Primary: 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 — 1.4; 1.4; 1.3; 1.3 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Botulinum Toxin Type A - Azzalure (Drug); Botulinum Toxin Type A - Vistabel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Galderma R&D
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	1.4; 1.4; 1.3; 1.3; 1.0; 1.0	—

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.

Eligibility Criteria

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;

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Data sourced from ClinicalTrials.gov (NCT01014871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.