Clinical trial NCT01014871: Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles
Official title: Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wrinkles
Keywords: Forehead Wrinkles Toxin
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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;

Primary outcomes:
measure: 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
timeFrame: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: La Charité Hospital
Study officials:
affiliation: La Charité Hospital, Berlin, Germany
name: Pr Rzany, MD
role: PRINCIPAL_INVESTIGATOR
References: