| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Improvement of existing scars |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10039589 |
| E.1.2 | Term | Scarring |
|
| 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 assess the effect of Juvista in improving the appearance of existing scars that are 2-6 months old. |
|
| E.2.2 | Secondary objectives of the trial |
| To assess the local safety and tolerance of Juvista when administered to existing scars that are 2-6 months old. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
General Inclusion Criteria:
The following general inclusion criteria are required to ensure that the patients included in the trial are suitable for entry in terms of their general health and the provision of informed consent.
- Male and female caucasian patients aged 18-65 years who have provided written informed consent.
- A body mass index between 15 and 35 kg/m2 (calculated using Quetelet’s index [weight (kg)/height m2].
- Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. All laboratory tests must be performed within 28 days of the first trial dose administration.
- Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one 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.
Scar Specific Inclusion Criteria:
The following scar specific inclusion criteria are required to ensure that patients included in the trial have suitable scars and that the scar area to be treated allows assessment of efficacy of the active study treatment against the placebo (i.e. symmetrical around the midline). The scar area being treated must be of the correct length and in a suitable area for accurate, representative photographs to be taken.
- The scar to be treated is 2-6 months old at Day 0.
- The scar area is linear.
- The scar area to be treated is symmetrical in appearance around the mid-line.
- The scar area to be treated is between 7cm and 20cm in length and a maximum of 1cm in width.
- The scar area to be treated runs along a flat surface which is in the same focal plane and suitable for accurate medical photography.
- The scar area to be treated is judged, in the opinion of the Investigator, to be redder than the surrounding normal skin.
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|
| E.4 | Principal exclusion criteria |
General Exclusion Criteria:
The general exclusion criteria are required to exclude patients whose medical history, ongoing conditions or lifestyle could affect the assessment of efficacy or safety during the trial.
The following criteria exclude patients who have compromised healing rates which may impact on scarring and subsequent treatment assessment:
- Patients who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing including :
Significant rheumatoid arthritis.
Significant hepatic impairment (LFTs >3 times upper limit of normal).
Inadequately or uncontrolled congestive heart failure.
Currently active malignancy or history of any malignancy in the 5 years prior to the screening visit.
Immunosuppression or chemotherapy in the twelve months prior to the screening visit.
A history of radiotherapy to the study scar area.
Diabetes mellitus (unless controlled by diet and exercise alone).
A bleeding disorder or current use of anti-thrombotic therapy (aspirin, ticlopidine and clopidogrel are permitted).
- Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula : CLcr = (140-age (years)) x weight(kg)/ 72 x serum creatinine (mg/dL) { x 0.85 for females }
- Patients 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 this trial.
The following criteria exclude patients who may not complete the trial assessments or who have conditions which may interfere with the assessment of drug safety:
- Patients with a history of clinically relevant allergy, hypersensitivity, angioedema, or anaphylaxis.
- Patients with a progressive neurological condition including Parkinson’s disease, Alzheimer’s disease and uncontrolled epilepsy.
- Patients with a known history of chronic viral infection (Hepatitis, HIV) or ongoing active infection.
- Patients with bleeding disorders including haemophilia, purpura or thrombocytopenia or receiving anticoagulants (e.g. warfarin, coumadin).
- Patients with an ongoing psychiatric condition requiring treatment or psychosis (including depression with psychosis, bipolar disease and schizophrenia.
- Patients with a history of clinically significant hypersensitivity to any of the drugs, surgical markers or surgical dressings to be used in this trial.
- Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- Patients undergoing investigations or changes in management for an existing medical condition.
- Female patients who are breast feeding, or intending to become pregnant or breast feed during the study period (subjects must be using adequate contraception and have a negative pregnancy test at screening).
- Female patients who have had any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipate any change during study participation
- In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
- Patients with a history of substance abuse or dependency (a history of recreational use of cannabis is acceptable assuming a negative urine test for cannabis at screen. Patients who have had a history of alcohol abuse but have been dependency free for 12 months will still be eligible).
Scar Specific Exclusion Criteria:
The following scar specific exclusion criteria are required to ensure that patients included in the trial do not have a history of keloid scarring as the efficacy of Juvista has not been determined in the treatment of keloid scars and will be evaluated as part of a separate development plan. The criteria also ensure that assessment of the scar area will not be compromised due to its close proximity to other scars. Patients involved in litigation regarding their scar are excluded until the litigation is concluded.
- Patients who on direct questioning and physical examination have a history or evidence of keloid scarring.
- Patients with additional scars less than 3cm away from the scar area to be treated.
- The scar to be treated is a facial scar.
- Patients who are involved in ongoing litigation in connection with the scar to be treated.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary trial endpoint is the improvement of scar appearance at 6 months post-treatment as assessed by calculating the colour difference (∆E) between the treated scar sections with reference to the surrounding skin.
The secondary efficacy endpoint is the difference in scar appearance between active and placebo treated sections at 6 months post treatment as assessed using a Global Scar Comparison Scale. |
|
| 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 | 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 |
|
| 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 | 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 | Yes |
| E.8.1.7.1 | Other trial design description |
| Within patient controlled |
|
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.5.1 | Number of sites anticipated in the EEA | 1 |
| 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 definition of the end of trial is the last scar assessment. This allows for the completion of all data collection e.g. photographs and panel assessments, in order to meet all relevant endpoints. |
|
| 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 | 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 | 7 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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