Moderate to severe forehead wrinkles MedDRA version: 9.1 Level: LLT Classification code 10040954 Term: Skin wrinkling
Conditions
Interventions
Trade Name: AZZALURE
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: botulinum toxin type A
Other descriptive name: neurotoxin from Clostridium botulinum
Concentration type
Sponsors
GALDERMA Research & Development
Eligibility
Sex/Gender
All
Inclusion 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; 4. Subjects of childbearing potential must practice a highly effective method of contraception during the study; 5. Subjects of non-childbearing potential; 6. Subjects having read and signed the approved Informed Consent Form prior to any participation in the study; 7. Subjects willing and capable of cooperating to the extend and degree required by the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than (see table below): • 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. Inability to substantially lessen forehead wrinkles by physically spreading them apart; 5. Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts); 6. Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics; 7. Concurrent treatment that, in the Evaluator’s opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments; 8. Active infection in the forehead area (e.g. acute acne lesions or ulcers); 9. Current facial palsy; 10. Marked facial asymmetry, excessive dermatochalasis, brow ptosis, deep dermal scarring or thick sebaceous skin; 11. Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert Syndrome or Amyotrophic lateral sclerosis); 12. Clinically diagnosed anxiety disorder or any significant psychiatric disorder (e.g. depression) that, in the opinion of the Evaluator, might interfere with the Subject’s participation in the study; 13. Current history of chronic drug or alcohol abuse; 14. Presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function) or circumstance that, in the judgment of the Evaluator, might increase the risk to the Subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study; 15. Pregnant women, nursing mothers, or women who are planning pregnancy during the study; 16. Participation in another investigational treatment or device research study within 30 days of enrolment; 17. Adult Subjects under guardianship, hospitalised Subjects in a public or private institution for a reason other than the research, and Subjects deprived of freedom.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to compare two botulinum toxins type A in terms of efficacy in the treatment of moderate to severe forehead wrinkles (2-3 on the Forehead Wrinkles Severity Scale). The safety of each botulinum toxin will be evaluated.;Secondary Objective: ;Primary end point(s): Efficacy • 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 • Subject’s assessment of onset of action: any noticeable effect on the appearance of forehead wrinkles at maximum contraction for each side of the forehead during the first 10 days • Evaluator’s assessment of onset of action: any noticeable effect on the appearance of forehead wrinkles at maximum contraction for each side of the forehead during the first 10 days • Right-left preference at each post-Baseline visit (at maximum contraction and at rest): ? by the Subject (Subject’s Preference) ? by the Evaluator (Evaluator’s Preference) • Electromyogram (EMG) at each study visit and for each side of the forehead (at maximum contraction) | — |
Countries
Germany
Outcome results
None listed