E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042503 |
E.1.2 | Term | Superficial basal cell carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 assess whether the combination of PDT followed by Mohs micrographic surgery is superior to Mohs micrographic surgery alone in treating basal cell carcinoma in terms of reducing the post Mohs wound defect as well as the mean number of stages required to achieve clearance.
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E.2.2 | Secondary objectives of the trial |
To assess the clinical lesion response (size reduction) with photodynamic therapy prior to Mohs micrographic surgery.
Cosmetic outcome assessed by the investigator and subject at 3 and 6 months post-operatively.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Male or female subjects older than 18 years.
2) The above should have a basal cell carcinoma at least 100 mm2 in surface area and appropriate for treatment with Mohs micrographic surgery..
3) Female subject of non-childbearing potential.
4) Subject must be willing and capable of cooperating with the study protocol.
5) ubject has to be able to read the Patient Information Sheet and read and sign the Informed Consent form prior to any procedure.
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E.4 | Principal exclusion criteria |
1) BCCs with less than 100 mm2 in surface area.
2) Clinically or histologically morphoeic basal cell carcinoma.
3) Female of child-bearing potential.
4) Subject with a history of porphyria, xeroderma pigmentosa or other photosensitive skin condition.
5) Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream.
6) Subject who is at risk in terms of precautions and contraindications in the package insert for Metvix®.
7) Subject who has participated in another investigational drug or device research study within 30 days of enrolment.
8) Subject with a condition or who is in a situation, which in the investigator’s opinion may put the subject at significant risk, may confound the study results or may interfere significantly with the subject’s participation in the study. This includes individuals unable to understand the implications or procedures of the trial, for example if they cannot adequately understand written or spoken English.
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E.5 End points |
E.5.1 | Primary end point(s) |
Measurement of wound defect surface area (mm2) after the Mohs micrographic surgery. The ratio of this to the original lesion size would be compared in the two groups.
Comparison of the mean number of stages of Mohs’ surgery required to achieve clearance in the two groups.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) To assess whether there is any reduction in size (surface area, mm2) of the lesion clinically with PDT prior to Mohs (in the Metvix® PDT group) including assessment of fluorescence between the first and second sessions of PDT.
2) Cosmetic outcome at months 3 and 6 after the Mohs surgery. Investigator assessment of cosmetic outcome:
3) Cosmetic outcome at month 3 and 6 by the subject. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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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 | 3 |
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 | 3 |
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 |