E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing scar revision surgery are left with scarring, which can vary from fine flat asymptomatic scars to hypertrophic scars. Studies show that these visible marks can cause emotional distress resulting in self-consciousness, loss of self-esteem, stigmatism and diminished quality of life. Scar revision relies on surgical technique to improve scars from complications following surgery, burns, trauma and injury. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039583 |
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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 investigate the efficacy of Juvista in the prevention or reduction of the resultant scar when applied to the approximated wound margins of subjects following scar revision surgery. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerance of Juvista when applied to the approximated wound margins of subjects following scar revision surgery.
To compare the surgical scar revision techniques of complete excision and staged excision. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects aged 18-85 years who have provided written informed consent
A body mass index between 15 and 35 kg/m2
Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol.
Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator
Subjects with linear scars that are suitable for revision by excision and direct closure.
Subjects who have stabilised, mature scars |
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E.4 | Principal exclusion criteria |
Subjects who have history or evidence of keloid scarring. Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar. Subjects with additional scars less than 3cm away from the area to be revised. Subjects with a history of a bleeding disorder. Subjects with diseases or conditions that could interfere with assessment of safety, tolerability or efficacy. Subjects who have had surgery in the area to be excised within one year of Day 0. Subjects with a skin disorder which could affect the healing of acute wounds. Subjects with evidence of past or present medical condition that would impair wound healing. Subjects with hypersensitivity to any drug or dressing in trial. Subjects who are taking, or have taken, any investigational drugs including Juvista within 3 months of screening. Subjects taking regular, continuous, oral corticosteroids. Subjects with psychiatric disorders. Subjects undergoing investigations or changes in management for an existing medical condition. Subjects who are or become pregnant up to and including Day 0 or who are lactating. Subjects who are not likely to complete the trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the Total Scar Score (ToScar) from the Independent External Scar Assessment Panel VAS scores following blinded review of scar photographs taken at each time trial point up to month 7. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | No |
E.8.1.6 | Cross over | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 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 | Information not present in EudraCT |
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 efficacy assessment following the 60 month visit (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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |