E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately severe wrinkles |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048042 |
E.1.2 | Term | Wrinkles |
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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 |
Clinical efficacy analysis |
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E.2.2 | Secondary objectives of the trial |
Safety, tolerability and histology analysis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects who are healthy and male or female. - Subjects who are ≥18 - ≤50 years of age. - Subjects with mild (Grade 3) or moderate (Grade 4) nasolabial folds. - Subjects with symmetrical nasolabial folds. - Subjects with no clinically significant body weight changes in previous 6 months (>5kg weight change). - Subjects who have voluntarily signed and dated an Informed Consent Form (ICF). - Subjects, who are, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.
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E.4 | Principal exclusion criteria |
- Subjects with no (Grade 1), minimal (Grade 2), severe (Grade 5) or very severe (Grade 6) nasolabial folds. - Subjects with previous use of injectable fillers into the nasolabial folds. - Subjects of afro-Caribbean origin. - Subjects with a known history of keloids. - Subjects with a know history of bleeding disorders. - Subjects with HIV therapy-associated lipodystrophy. - Subjects with active skin disease (e.g. cysts, infections, rashes, cancer/pre-cancer) in the nasolabial folds. - Subjects with a known allergy to any of the constituents of the product (appendix 3). - Subjects with known or suspected malignancy. - Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc). - Subjects with an intolerance to additional study-associated drugs/therapies (e.g. isopropyl alcohol, EMLA cream, adrenaline, lignocaine etc). - Subjects with planned major surgical intervention during the course of the study. - Subjects taking immunosuppressive therapy including systemic steroids (i.e., oral prednisolone >40mg for more than 1 week, intranasal/inhaled steroids are acceptable) within 90 days of the first treatment or planning immunosuppressive therapy at any time during the study. - Subjects with known idiopathic or drug-associated coagulopathies. - Subjects taking medicinal products known to reduce haemostasis (e.g. heparin, coumarins, aspirin etc) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce haemostasis during the 28-day treatment phase. - Subjects who have taken any other investigational product within 90 days prior to screening or planned use of any other investigational product during the study period. - Subjects who are pregnant, planning pregnancy and women of child-bearing potential who are not abstinent or practising an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase. - Subjects with abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant. - Subjects with known alcohol or narcotic drug dependence.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Clinical assessment of change in the severity grade of nasolabial folds (6-point photographic scale) at each visit except screening. • Volumetric assessment of nasolabial folds (3D facial imaging) at baseline, week 12 and week 24. • Investigator satisfaction (10-point visual analogue scale) at week 12 and week 24. • Subject satisfaction (10-point visual analogue scale) at weeks 12 and week 24.
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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 | Yes |
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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Last visit of last subject as defined in protocol. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |