E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | LLT |
E.1.2 | Classification code | 10066677 |
E.1.2 | Term | Chronic leg ulcer |
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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 determine if repeat dose antimicrobial photodynamic therapy with PPA904 and PPA Lux 680 can cause a reduction in the bacterial content of chronic leg ulcers. |
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E.2.2 | Secondary objectives of the trial |
To determine if repeat dose antimicrobial photodynamic therapy with PPA904 and PPA Lux 680 can improve the healing of chronic leg ulcers. To assess the potential for systemic exposure of PPA904 following topical application to chronic leg ulcers and photoactivation with PPA Lux 680. To monitor the safety of repeat dose antimicrobial photodynamic therapy with PPA904 and PPA Lux 680 for the treatment of chronic leg ulcers. To assess the geometry of PPA Lux 680 for the treatment of chronic leg ulcers and to identify any concerns in practice of using PPA Lux 680.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible for the study subjects will be required to satisfy the following criteria: Subjects will be males or females of non child bearing status over 18 years of age. Subjects will have a chronic leg ulcer with an ABPI ≥ 0.6 (measured at screening). Subjects will have an ulcer that has been present for at least 3 months and not more than 3 years (Parts 1 and 2 only) Subjects will have an ulcer that has been present for at least 3 months (Part 3 only). Subjects will have an ulcer with an area of 2 – 100cm2 and a maximum linear dimension of 10cm. Subjects will have an ulcer with a total bacterial load of ≥ 104 CFU / cm2, determined within 2 weeks before the first treatment. Subjects will have voluntarily signed and dated a subject Informed Consent Form (ICF). Subjects will be, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and be willing to return to the clinic for all the required follow-up visits. Subjects should be of appropriate health to participate in the study, as determined by the Investigator. This will be determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
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E.4 | Principal exclusion criteria |
Subjects under the age of 18 years of age. Subjects who have applied topical antibiotics to the target ulcer or immediate surrounding areas during the 2 weeks prior to screening. Subjects who have taken systemic antibiotics during the 2 weeks prior to screening. Subjects who have used any anti-microbial dressing or topical antiseptic / antimicrobial or received maggot therapy on the target ulcer or immediate surrounding areas during the 2 weeks prior to screening. Subjects who have evidence of connective tissue disorders e.g. vasculitis or rheumatoid arthritis under active treatment. Subjects who have any clinically significant medical condition that would impair wound healing as determined by the investigator, including uncontrolled diabetes as determined by HbA1C (>12%) or immune disease. Subjects who are known to abuse alcohol or drugs currently, or to have psychological disorders that could affect follow-up care or treatment outcomes. Subjects who have received short course corticosteroids within 30 days. Subjects who have participated in a clinical trial of any investigational drug within 4 months prior to treatment. Subjects who have participated in a clinical trial of any investigational device, for example dressings, within 1 month prior to treatment. Subjects who have or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment. Subjects with evidence of exposed bone, tendon or facia visible around the target wound. Subjects with photosensitivity disorders. Subjects with systemic infection, whether or not related to their ulcer. Subjects with clinically relevant (assessed by PI) active wound infection undergoing treatment.
Additional Exclusion Criteria Following study assessments at each visit, subjects may be excluded from the study for the following reasons: Intercurrent illness or clinically significant adverse events. Subjects who have applied any topical antiseptics / antimicrobials / antibiotics or used antimicrobial dressings to the target ulcer or immediate surrounding areas. . Assessments performed up to the time of application will be included in the analysis. Subjects who have taken systemic antibiotics. Data up to that point will be included in the analysis.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is: Measurement of the total bacterial load of the ulcer immediately pre and immediately post each dose.
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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 | 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 | 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 | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Blinded to patients and all study staff except those dispensing and administering IMP and monitors |
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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
| 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 | 10 |
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 | Yes |
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 |
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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 | 18 |
E.8.9.1 | In the Member State concerned days | |