E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Actinic keratosis |
Aktinische Keratose |
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E.1.1.1 | Medical condition in easily understood language |
Actinic keratosis |
Aktinische Keratose |
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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 | 17.0 |
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.
See also E5 (endpoints) |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Immunocompetent women or men at least 18 years of age
2. Informed consent (signed)
3. Diagnosis: actinic keratosis
4. Area requiring treatment of about 50 cm2 in total located on the face and/or (hairless) scalp. The area should be chosen that a continuous surface forms.
5. Within the area requiring treatment: not less than 7 distinct lesions that should be identifiable with the following characteristics: clinical mild to moderate degree, at least 4 mm in diameter, nonhypertrophic, not severe hyperkeratotic
6. Women of child bearing potential: use of a highly effective method of contraception during the whole duration of the clinical trial
7. Women: negative pregnancy test prior to start of treatment
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E.4 | Principal exclusion criteria |
1. Presence of the following skin diseases at the treatment area: carcinoma (e.g. basal cell carcinoma, squamous cell carcinoma), eczema like atopic dermatitis, psoriasis vulgaris, Rosacea papulopustulosa or other possible confounding conditions
2. Hypertrophic, severe hyperkeratotic actinic keratosis lesions within the treatment area that have to be characterized as severe actinic keratosis
3. Systemic retinoid therapy within six months prior to treatment start
4. Systemic therapy with immunomodulators, immunosuppressive drugs, interferon, glucocorticoids or cytotoxic drugs within 28 days prior to treatment start
5. Therapies or use of chemical peel, dermabrasion, PUVA or UVB therapy at the treatment area within six months prior to treatment start
6. Cryodestruction, curettage, laser abrasion, photodynamic therapy, 5-fluorouracil, diclofenac, imiquimod, retinoid or other treatment of the actinic keratosis or topical glucocorticoid treatment at the treatment area 28 days prior to treatment start
7. Known allergy or hypersensitivity to diclofenac or one of the other excipient of the test products
8. Pseudoallergic reactions like asthma, rhinitis or urticarial to acetyl salicylic acid or other NSAIDs in medical history
9. Presence of gastrointestinal ulceration or bleeding
10. 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 reduction of the Target Lesion Number Score (TLNS) of ≥ 75% at the final examination |
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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) |
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E.5.2 | Secondary end point(s) |
- Proportion of patients with a TLNS reduction of ≥ 75% at the end of treatment
- Changes of the severity of the target lesions in comparison to the situation before Treatment
- 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
- 100 % clearance of all AK lesions at the final examination (CLNS =0) and proportion of patients with 100 % reduction of the TLNS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Different, depending on the end Point, see E.5.2 |
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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.8.5 | 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 | |
E.8.9.2 | In all countries concerned by the trial years | 1 |