E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subclinical lesions in UV-exposed areas of chronically UV-damaged skin in the face adjacent to lesions caused by actinic keratosis but not obviously affected themselves. |
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E.1.1.1 | Medical condition in easily understood language |
Facial skin areas chronically damaged by sunlight (UV light) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
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 |
The primary objective of this study is the unmasking of sub-clinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin. |
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E.2.2 | Secondary objectives of the trial |
o Efficacy of the treatment with Tirbanibulin o Assessment of the sun-damage skin after the treatment by UV photography (Canfield VISIA®) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) Informed consent (2) Diagnosed with sun-damaged skin on the face and AK in the treatment area (3) Willing and able to comply with all study procedures (4) Use of medically acceptable contraception in males or females of child-bearing potential (5) 51 -100 years of age (6) Negative pregnancy test at baseline in females of childbearing potential |
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E.4 | Principal exclusion criteria |
(1) Allergy or intolerance towards the active ingredient or any of the constituents of the IMP (2) Any contraindication for the IMP, according to the most recent version of the SmPC (3) Open lesions of any kind on the face (4) Concomitant cutaneous malignancy in treatment area, including but not restricted to squa-mous skin cancer (5) Immune deficiency (6) Participation in another clinical trial during the last six months (7) Pregnancy or lactation (8) Excessive exposure to UV radiation during study period (9) Any contraindication against the use of UV imaging for diagnosis (10) Dependent on the sponsor / PI, e.g., as an employee (11) Unable or unwilling to understand the purpose of the study, or to comply with study-related procedures |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is total clearance (CIR) rates of unmasked lesions (57 ± 7 d) after the start of the treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
57 ± 7 d after the start of the treatment |
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E.5.2 | Secondary end point(s) |
o Percentage of patients with unmasked subclinical lesions at each visit o Partial clearance rates of unmasked lesions at 57 ± 7 d after the start of the treatment (FuV) o Quantification of skin findings (AK lesions, subclinical lesions, sun damage, local skin reaction [LSRs], and other changes of the skin, which are not necessarily clinically relevant) at each visit. Safety is analysed by means of adverse events. Local skin reactions are recorded and graded separately. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
57 ± 7 d after the start of the treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |