| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
Mejoría en la apariencia de cicatrices
Improvement of scar appearance |
|
| 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 confirm the efficacy of Juvista (avotermin) in the improvement of scar appearance when administered intradermally to the approximated wound margins of patients following scar revision surgery of disfiguring scars. |
|
| E.2.2 | Secondary objectives of the trial |
| To assess the safety and tolerance of Juvista (avotermin) when administered intradermally to the approximated wound margins of patients following scar revision surgery of disfiguring scars. |
|
| 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.
- Patients aged 18-85 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.
- If females of child bearing potential, patients must be 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 disfiguring scars which are suitable for surgical revision. The criteria also ensure that the scar area to be revised is suitable to assess the efficacy of the active study treatment against the placebo (i.e. symmetrical around the midline). The scar areas must be of the correct length and in a suitable area for accurate, representative photographs to be taken. Patients may have an entire scar revised or partial revision of an existing scar where a suitable area of a scar fits the required criteria.
- The scar area to be revised is disfiguring. To be considered disfiguring for this trial scars must have at least one of the following characteristics.
*Scar area 13 or more cm in length.
*Scar area at least 0.6 cm wide at widest part.
*Surface contour of scar area elevated or depressed on palpation.
*Scar area adherent to underlying tissue.
*Skin hypo-or hyper-pigmented in an area exceeding 39 cm2.
*Skin texture abnormal (irregular, atrophic, shiny, scaly, etc.) in an area exceeding 39 cm2.
- The scar to be revised is at least 12 months old.
- The investigator considers that the appearance of the scar area to be revised can be improved with surgery alone.
- The scar area is linear and suitable for revision by excision and direct closure.
- The scar area to be revised is symmetrical in appearance around the mid-line.
- The scar area to be revised is between 7cm and 20cm in length.
- The scar area to be revised runs along a flat surface which is in the same focal plane and suitable for accurate medical photography.
- The scar is approved for entry into the trial by the Independent Expert Screening Panel. |
|
| 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.
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 who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits.
- Patients with a history of clinically significant hypersensitivity to any of the drugs 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 (excluding the scar for revision).
- Patients who are or who become pregnant up to and including Day 0 or who are lactating.
- In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
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 revision of keloid scars and will be evaluated as part of a separate development plan. The criteria also ensure that the revised scar will not be distorted by nearby anatomical structures and that assessment of the scar 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. Revision surgery should not be conducted on scars less than one year old as they may not have reached maturity.
- Patients who on direct questioning and physical examination have history or evidence of keloid scarring.
- Patients with scar areas for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar or difficulty in taking photographs.
- Patients with additional scars less than 3cm away from the area to be revised.
- Patients with scars that require revision using Z-plasty, W-plasty or any other such techniques.
- Patients who are involved in ongoing litigation in connection with the scar to be revised.
- Patients who have had surgery in the area to be excised within one year of Day 0. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary trial endpoint is the improvement of Juvista treated scars compared with placebo treated scars at 12 months post-surgery as assessed by an independent expert clinical panel using a Global Scar Comparison Scale.
The key secondary endpoint is the improvement of Juvista treated scars compared with placebo treated scars at 12 months post-surgery as assessed by the patient 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 | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| 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) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| 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 |
|
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 50 |
| 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
|
| This trial formally ends after completion of the last scar assessment by the expert clinical panel following the Month 12 visit. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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