E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe forehead wrinkles |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040954 |
E.1.2 | Term | Skin wrinkling |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |