E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Facial skin imperfections such as small scars, depressions, pock-marks and other localised contour deformities of healthy adults |
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MedDRA Classification |
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 and tolerability analysis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects who are healthy and male or female. 2. Subjects who are 18 - 55 years of age. 3. Subjects with discreet facial skin imperfection(s). 4. Subjects with no clinically significant body weight changes in previous 6 months (>5kg weight change). 5. Subjects who have voluntarily signed and dated an Informed Consent Form (ICF). 6. 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 |
1. Subjects with previous use of injectable fillers into the facial skin imperfections. 2. Subjects with previous use of cellular therapy (e.g Isolagen). 3. Subjects of Afro-Caribbean origin. 4. Subjects with a known history of keloids. 5. Subjects with a know history of bleeding disorders. 6. Subjects with HIV therapy-associated lipodystrophy. 7. Subjects with active skin disease (e.g. cysts, infections, rashes, cancer/pre-cancer) in the facial skin imperfections. 8. Subjects with active skin infection including acne. 9. Subjects with a known allergy to any of the constituents of the product (appendix 3). 10. Subjects with known or suspected malignancy. 11. Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc). 12. Subjects with an intolerance to additional study-associated drugs/therapies (e.g. isopropyl alcohol, AneStop cream, adrenaline, lignocaine etc). 13. Subjects with planned major surgical intervention during the course of the study. 14. 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. 15. Subjects with known idiopathic or drug-associated coagulopathies. 16. Subjects taking medicinal products known to reduce haemostasis (e.g. heparin, coumarins etc) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce haemostasis during the 24 week study period. 17. 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. 18. 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. 19. 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. 20. Subjects with known alcohol or narcotic drug dependence.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints: • Clinical assessment of skin imperfections at each visit except screening, using digital photography
• Investigator satisfaction (10-point visual analogue scale) at week 12 and 24
• Subject satisfaction (10-point visual analogue scale) at week 12 and 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 | No |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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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Last visit of last subject as defined in the 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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |