E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 14.0 |
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 |
Evaluation of the efficacy and safety of a new diclofenac 3% gel formulation vs. the originator Solaraze (licensed) vs. vehicle in patients with actinic keratosis |
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E.2.2 | Secondary objectives of the trial |
The following parameters are defined as secondary in the study protocol:
Course of the cumulative lesion number score (CLNS) between beginning of treatment (day 0) and final examination or early termination.
Evaluation of the global improvement by the investigator (IGII) and by the patient (PGII) during the whole study course.
Proportion of patients with the IGII rating "cured" at final examination. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) immunocompetent men or women, 18 years or older
2) written consent form
3) diagnosis: actinic keratosis
4) at least five (5) and no more than ten (10) clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter, contained within a 25-cm² treatment area located on the face or bald scalp
5) women of child bearing potential: use of a highly effective method of contraception during the whole course of the study
6) women: negative pregnancy test prior to study start |
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E.4 | Principal exclusion criteria |
1) presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, sunburn or other possible confounding skin conditions in or near the treatment area
2) use within six months prior to randomization of oral retinoids
3) use within one month prior to randomization of immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids or cytotoxic drugs
4) use within six months prior to randomization on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, PUVA therapy, or UVB therapy
5) use within one month prior to randomization on the face or bald scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, or other treatment for actinic keratosis
6) known allergy or hypersensitivity to diclofenac or other excipients in one of the test products
7) known hypersensitivity reactions like asthma, rhinitis or urticaria to acetyl salicylic acid or other NSAIDs in the past
8) active gastrointestinal ulceration or bleeding
9) severe renal or hepatic impairment
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the proportion of patients in the per protocol population with treatment success (100% clearance of all AK lesions within the treatment area) at the final examination (30 days after completion of 90 days of treatment). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Start of therapy (day 0) and end of study (day 120, visit 5). |
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E.5.2 | Secondary end point(s) |
1) Course of the cumulative lesion number score (CLNS) between beginning of treatment (day 0) and final examination or early termination.
2) Evaluation of the global improvement by the investigator (IGII) and by the patient (PGII) during the whole study course.
3) Proportion of patients with the IGII rating "cured" at final examination.
4) Evaluation of the tolerability of the treatment by the investigator and the patient
5) safety laboratory
6) assessment of adverse events in the course of the study
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) at every visit
2), 4), 6) every visit from visit 2 on
3) last visit (visit 5)
5) begin (visit 1) and end of therapy (visit 4)
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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 | 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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 6 |
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 | 2 |
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 | 2 |
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 |