E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients over 18 years of age two similar areas with actinic keratoses and field-cancerized skin of each at least 50 cm2 |
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E.1.1.1 | Medical condition in easily understood language |
Patients with solar keratoses and sundamaged skin in a two comparable skin area of at least 50 cm2 each |
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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 | 19.0 |
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 |
Comparison of treatment efficacy of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses |
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E.2.2 | Secondary objectives of the trial |
Local skin reactions following pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients over 18 years old with two similar skin areas of each 50 cm2, 5 actinic keratosis, and field-cancerization Fertile women with negative pregnancy test and using safe contraception |
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E.4 | Principal exclusion criteria |
porphyria allergy to Metvix creme infiltrating tumours in treatment area Photodynamic therapy or laser therapy within 1 months of treatment area pregnant or lactating women |
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E.5 End points |
E.5.1 | Primary end point(s) |
Treatment efficacy assessed as lesion complete response rate, defined as as number of actinic keratosis at 12 weeks post-treatment compared to baseline in each patient
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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) |
local skin reactions after treatment evaluated as acute reactions: erythema, oedema, crusting, scaling, pustules and late reactions: hypopigmentation, hyperpigmentation or scars
New actinic keratoses in treatment area compared to baseline Pain during laser treatment and daylight exposure Cosmetic outcome assessed by patient and investigator Photorejuvenation from baseline photos evaluated by investigator |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
acute skin reactions: day 1-5 after treatment pain: during treatment cosmetic outcome, photorejuvenation and late skin reactions: 12 weeks after treatment |
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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 | No |
E.8.1.3 | Single blind | Yes |
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 |
pretreatment with ablative fractional laser versus microdermabrasion |
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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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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 | 9 |
E.8.9.1 | In the Member State concerned days | |