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 | 10000614 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 a nanoemulsion gel formulation containing 10% 5?aminolevulinic acid (ALA) as active ingredient (also referred to as BF-200 ALA 10% or BF-200 ALA) with the marketed product Metvix® and with placebo, for the treatment of actinic keratosis with photodynamic therapy. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and secondary efficacy parameters related to BF-200 ALA 10% gel for treatment of actinic keratosis with photodynamic therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main inclusion criteria: 1) Written Informed Consent 2) Men and women between 18 and 85 years of age 3) 4-8 actinic keratosis lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (Olsen grade 1 and 2) in the face and/or on the bald scalp. Lesions on the eyes, nostrils, ears and mouth will not be considered for a treatment during the planned study. 4) Target actinic keratosis (AK) lesions must be discrete and quantifiable; adjacent AK lesions must show a minimum distance of 1.0 cm from one another 5) Confirmation of AK by biopsy taken at screening 6) Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment region that may cause difficulty with examination or final evaluation 7) Willingness to stop the use of moisturizers and any other topical treatments within the treatment region 8) Good general health condition 9) Healthy patients and patients with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis) will be permitted to be included into the study if the medication taken for the treatment of the disease does not match an exclusion criterion or is specified as prohibited concomitant medication 10) No extensive sunbathing or solarium use during the trial 11) Negative pregnancy test at screening 12) Effective contraception in women of childbearing potential
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E.4 | Principal exclusion criteria |
Main exclusion criteria: 1) Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations 2) Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult 3) Presence of photodermatoses 4) Presence of other tumors in the treatment areas within the last 4 weeks 5) Intake of phototoxic or photoallergic drugs 6) Current treatment with immunosuppression therapy 7) Hypersensitivity to porphyrins 8) Presence of porphyria 9) Presence of inherited or acquired coagulation defect 10) Any topical treatment within the treatment area within 12 weeks before PDT-1 11) Topical treatment with ALA or MAL outside the treatment area during participation in the study 12) None of the specified systemic treatments within the designated period before PDT-1
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy analysis variable is the overall patient complete response rate assessed 12 weeks after the last PDT. A patient is classified as an overall complete responder if all treated lesions are cleared after either PDT-1 or PDT-2, if re-treated. A missing 12-week assessment may be imputed by the preceding 4-week assessment using a last observation carried forward approach. In case no assessment is available at all, the patient will be regarded as a non-responder. |
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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 | No |
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) | 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 | 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 |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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End of trial is defined as the planned date for last patient last visit (September/October 2009). |
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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 | 20 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 20 |