Wrinkles
Conditions
Keywords
Forehead Wrinkles Toxin
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.
Interventions
DRUGBotulinum Toxin Type A - Azzalure
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.
DRUGBotulinum Toxin Type A - Vistabel
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.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5 | 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. |
Countries
Germany
Participant flow
Recruitment details
Recruitment process: patients from private practice - Recruitment period: First Patient In = 13 July 2009 Last Patient In = 09 November 2009 - Type of location: hospital
Participants by arm
| Arm | Count |
|---|---|
| Vistabel/Azzalure at Baseline:
* 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead
* 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Vistabel/Azzalure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment Germany | 30 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 30 | 18 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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
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.
Time frame: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5
Population: Intention To Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azzalure | 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 | Baseline at rest | 1.4 Scores on a scale | Standard Deviation 0.5 |
| Azzalure | 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 | Day 2 at rest | 1.0 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 10 at rest | 0.5 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 3 at rest | 0.9 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 2 at maximum contraction | 1.6 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 30 at rest | 0.6 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 3 at maximum contraction | 1.2 Scores on a scale | Standard Deviation 0.7 |
| Azzalure | 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 | Day 7 at rest | 0.7 Scores on a scale | Standard Deviation 0.7 |
| Azzalure | 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 | Day 7 at maximum contraction | 0.7 Scores on a scale | Standard Deviation 0.7 |
| Azzalure | 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 | Month 4 at rest | 1.0 Scores on a scale | Standard Deviation 0.5 |
| Azzalure | 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 | Day 10 at maximum contraction | 0.6 Scores on a scale | Standard Deviation 0.7 |
| Azzalure | 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 | Day 14 at rest | 0.6 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 14 at maximum contraction | 0.5 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Month 5 at rest | 1.2 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 30 at maximum contraction | 0.5 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Baseline at maximum contraction | 2.1 Scores on a scale | Standard Deviation 0.3 |
| Azzalure | 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 | Month 4 at maximum contraction | 1.5 Scores on a scale | Standard Deviation 0.5 |
| Azzalure | 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 | Day 1 at rest | 1.3 Scores on a scale | Standard Deviation 0.5 |
| Azzalure | 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 | Month 5 at maximum contraction | 1.8 Scores on a scale | Standard Deviation 0.6 |
| Azzalure | 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 | Day 1 at maximum contraction | 1.8 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Month 5 at maximum contraction | 1.9 Scores on a scale | Standard Deviation 0.5 |
| Vistabel | 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 | Day 3 at rest | 0.8 Scores on a scale | Standard Deviation 0.5 |
| Vistabel | 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 | Baseline at rest | 1.4 Scores on a scale | Standard Deviation 0.5 |
| Vistabel | 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 | Day 7 at rest | 0.7 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Day 10 at rest | 0.5 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Day 1 at rest | 1.3 Scores on a scale | Standard Deviation 0.5 |
| Vistabel | 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 | Day 14 at rest | 0.5 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Day 30 at rest | 0.6 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Month 4 at rest | 1.0 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Baseline at maximum contraction | 2.1 Scores on a scale | Standard Deviation 0.3 |
| Vistabel | 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 | Day 1 at maximum contraction | 1.8 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Day 2 at rest | 1.0 Scores on a scale | Standard Deviation 0.5 |
| Vistabel | 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 | Day 2 at maximum contraction | 1.5 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Day 3 at maximum contraction | 1.1 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Day 7 at maximum contraction | 0.7 Scores on a scale | Standard Deviation 0.7 |
| Vistabel | 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 | Day 10 at maximum contraction | 0.6 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Day 14 at maximum contraction | 0.4 Scores on a scale | Standard Deviation 0.5 |
| Vistabel | 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 | Day 30 at maximum contraction | 0.5 Scores on a scale | Standard Deviation 0.5 |
| Vistabel | 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 | Month 4 at maximum contraction | 1.4 Scores on a scale | Standard Deviation 0.6 |
| Vistabel | 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 | Month 5 at rest | 1.3 Scores on a scale | Standard Deviation 0.6 |