E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acceleration of split thickness skin graft donor sites |
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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 | PT |
E.1.2 | Classification code | 10036892 |
E.1.2 | Term | Promotion of wound healing |
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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 compare the efficacy of two concentrations of Juvidex with placebo on the healing of split thickness skin graft donor sites. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerance of two concentrations of Juvidex when administered by intradermal injection and/or topically to split thickness skin graft donor sites.
To compare the efficacyof placebo with standard care on the healing of split thickness skin graft donor sites. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Protocol RN1004-0084, 17 October 2007, Version 1.0.
This study is a pharmacogenomic analysis of blood samples to identify polymorphisms that segregate responders from non-responders following treatment with Juvidex of split thickness skin graft donor sites in Renovo clinical study RN1004-0082 |
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E.3 | Principal inclusion criteria |
1. Subjects aged 18-85 years who have given written informed consent
2. A body mass index between 18-35 calculated using Quetelets index
3. Subjects with, in the opinion of the investigator, clinically acceptable results for the laboratory tests and ECG as specified in the trial protocol. All laboratory tests must be performed within 28 days of the first trial dose administration
4. Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least screening visit until 1 month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner. |
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E.4 | Principal exclusion criteria |
1. Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring
2. Subjects with tattoos, birthmarks, moles or previous scars within 3cm of the area to be investigated during the trial
3. Afro-carribean subjects because of their increased susceptibility to hypertrophic and keloid scarring
4. Subjects who have had surgery in the area to be investigated within 1 year of the first dosing day
5. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in the trial
6.Subjects with any clinically significant medical condition or history of any condition that would impair wound healing, including: (a) subjects with renal impairment (CLcr < 80/ml/min) (b) significant hepatic impairment (LFTs>3 times upper limit of normal) (c) Congestive heart failure with a classification of >2 (NYHA classification) (d) History of myocardial infarction, ischaemic heart disease (or presenting with symptoms or signs compatibile with ischaemic heart disease), coronary vasospasm or peripheral vascular disease (e) Subjects with significant cerebrovascular disease including a history of stroke, transient ischaemic attacks or haemorrhage (f) Malignancy (unless treated and disease-free for 5 years) (g) Autoimmune disease (including active rheumatoid arthritis), immunosupression (oral corticosteroids) or chemotherapy within the last 12 months (h) uncontrolled hypertension SBP>180mmHg, DBP>95mmHG (i) Diabetes (except diet controlled) (j) significant respiratory disease
(7) subjects with a history of clinically relevant allergy, hypersensitivity, angioedema or anaphylaxis
(8) Subjects with a progressive neurological condition including Parkinson's disease, Alzheimer's disease and uncontrolled epilepsy
(9) Subjects with a history of chronic viral infection (Hepatitis, HIV) or ongoing active infection
(10) Subjects with bleeding disorders including haemophilia, purpura or thrombocytopenia or receiving anticoagulants (e.g. warfarin, coumadin)
(11) Subjects who have taken any investigational product in the 12 months prior to first trial dose administration
(12) Subjects undergoing investigations or changes in management for an exisiting medical condition
(13) Subjects with a history of substance abuse or dedpendency (history of recreational use of cannabis is acceptable assuming a negative urine test for cannabis at screen). Subjects who have had a history of alcohol abuse but have been dependency free for 12 months will still be eligible.
(14) Subjects with any condition or serious illness which in the opinion of the investigator would intefere with study participation
(15) Subjects with ongoing psychiatric condition requiring treatment or psychosis
(16) Female subjects who are breast feeding or intending to become pregnanct or breast feed during the study
(17) Femal subjects who have had any change in their oral contraceptive medication in the 2 months prior to day 0, or anticipate any change during study participation |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary trial endpoint will be the time to complete wound closure (100% re-epithelialisation) at the skin graft donor site as assessed by the investigating physician. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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
| 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
|
The End of Trial is defined as the last donor site photograph to be assessed by the Clinical Assessment Panel since this is the last efficacy assessment made for 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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |