E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate-to-severe glabellar lines |
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E.1.1.1 | Medical condition in easily understood language |
lines between the eyebrows and above the nose |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052609 |
E.1.2 | Term | Glabellar frown lines |
E.1.2 | System Organ Class | 100000004858 |
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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 |
to demonstrate the safety and efficacy of DWP-450 purified botulinum neurotoxin, Type A in treatment of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult subjects at maximum frown. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Subject is an adult, of at least 18 years of age
-Subject understands and signs the informed consent and can comply with study instructions
-Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS (GLS=2 or 3)
-Subject is willing and able to complete the entire course of the study
-Subject finds their glabellar lines have an important psychological impact (on mood, anxiety and/or depressive symptoms) |
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E.4 | Principal exclusion criteria |
A subject must not meet the following key exclusion criteria in order to be eligible for enrollment in the study:
-Previous treatment with botulinum toxin of any serotype in the forehead area within the last 6 months
-Previous treatment with any facial aesthetic procedure (e.g., injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
-Previous insertion of permanent material in the glabellar area
-Planned treatment with botulinum toxin of any serotype in any other body region during the study period
-Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
-Energy based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
-Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (can continue with their usual skin care routine)
-Subjects not reasonably expected to respond to 20 units of botulinum toxin (e.g., inability to substantially lessen glabellar frown lines even by physically spreading them apart)
-Marked facial asymmetry
-Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis
-History of facial nerve palsy
-Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
-Any active infection or history of herpes simplex or herpes zoster in the area of the injection sites
-Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
-History of dysphagia or aspiration
-Subjects with prolonged bleeding times. If on a drug or supplement that prolongs bleeding times (eg non-steroidal, anti-inflammatory, anticoagulant, fish oil), wait 10 days or until bleeding times return to normal before injecting
-Evidence of recent alcohol or drug abuse
-Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
-Breast feeding, pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
-Individuals who may be unduly influenced or fear a retaliatory response by hierarchy at the study center during the study
-Known allergy or hypersensitivity to botulinum toxin preparation
-Participation in another interventional clinical study within the last 30 days |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy measure will be based on the investigators assessment of the subject using the four-point Glabellar Line Scale (0=none, 1=mild, 2=moderate, 3=severe) at maximum frown. The primary endpoint for assessing the efficacy of DWP-450 is the proportion of subjects with a GLS score of 0 or 1 on Day 30 (±3 days), post injection of a study drug. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Proportion of subjects with at least a 1 point improvement in the GLS from Day 0 to Day 2 at maximum frown by Investigator assessment
2) Proportion of subjects with a GLS score of 0 or 1 on Day 30, at maximum frown by subject assessment
3) Proportion of subjects with at least a 1 point improvement in Subject Satisfaction from Day 0 to Day 30 (±3 days)
4) Difference between the mean HAD Scale scores from Day 0 to Day 90
5) Proportion of subjects with at least a 1 point improvement in the GLS from Day 0 to Day 150 at maximum frown by Investigator assessment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Day 0-2
2) Day 30
3) Day 30 (±3 days)
4) Day 90
5) Day 150 |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
France |
Germany |
Sweden |
United Kingdom |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |