E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Actinic Keratosis |
Cheratosi Attinica |
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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] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 confirm the efficacy of LEO 43204 gel (0.018% for face/chest) in AK when applied topically once daily for three consecutive days as field treatment |
Confrontare l'efficacia a breve termine dell'applicazione topica una volta al giorno per 3 giorni consecutivi di LEO 43204 gel 0,018% e di un gel veicolo per il trattamento localizzato della CA |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of LEO 43204 gel (0.018% in face/chest) in AK when applied topically once daily for three consecutive days as field treatment. To evaluate the long term efficacy of LEO 43204 gel (0.018% for face/chest) in AK in an extended 12-month follow-up period after initial complete clearance at Week 8
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To evaluate the safety of LEO 43204 gel (0.018% in face/chest) in AK when applied topically once daily for three consecutive days as field treatment. To evaluate the long term efficacy of LEO 43204 gel (0.018% for face/chest) in AK in an extended 12-month follow-up period after initial complete clearance at Week 8 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the face or chest |
Soggetti con 5-20 CA clinicamente tipiche, visibili e distinte in un'area di trattamento di cute fotodanneggiata sull'intero viso o in un'area contigua di circa 250 cm2 sul torace |
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E.4 | Principal exclusion criteria |
-Location of the treatment area (full face or chest) •within 5 cm of an incompletely healed wound •within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
-Treatment with ingenol mebutate gel in the treatment area within the last 12 months
-Lesions in the treatment area that have: atypical clinical appearance (e.g. hypertrophic, hyperkeratotic or cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions) |
-Localizzazione dell'area di trattamento (intero viso o torace) •entro 5 cm da una ferita non completamente guarita •entro 5 cm da un sospetto carcinoma cutaneo basocellulare (BCC) o squamocellulare (SCC)
-Trattamento con ingenolo mebutato gel nell'area di trattamento negli ultimi 12 mesi
-Lesioni nell'area di trattamento che presenta: aspetto clinico atipico (e.g.ipertrofiche, ipercheratosiche o corni cutanei) e/o malattia recalcitrante ( e.g. non responsiva a crioterapia in almeno due precedenti occasioni) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Complete clearance at Week 8, defined as no clinically visible AKs in the treatment area |
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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) |
-Partial clearance at Week 8, defined as at least 75% reduction in the number of clinically
visible AKs in the treatment area
-Partial clearance at Week 4, defined as at least 75% reduction in the number of clinically
visible AKs in the treatment area
-Percent reduction in AK count in the treatment area at Week 8 compared to baseline |
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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 | No |
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 | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
| 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 |
Canada |
Germany |
Italy |
Spain |
United States |
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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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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 | 6 |
E.8.9.1 | In the Member State concerned days | 4 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 17 |