E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study will investigate the long term effects of Aldara® and Solaraze® on Actinic keratoses (AKs) on the face or scalp. AKs are defined as keratotic macules, papules or plaques with superficial scale on a red base, occurring on areas of extensive damage through sunlight. AKs are mainly induced by non-ionised radiation, especially through chronic UV-exposition, primarily sunlight. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
|
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 the study is to compare the long-term outcome of treatment with Aldara® 5% cream (IMIQ) and Solaraze® 3% gel (DIC) regarding recurrence rates. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives include the time to recurrence, long-term clinical outcome with respect to development of invasive SCC (squamous cell carcinoma), progression of SCC, need of rescue treatment, haematological changes, and cosmetic outcome. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible, a patient must comply with all of the following criteria: 1. Immunocompetent patient. 2. A study treatment area (STA) must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area. 3. A positive histological finding for early in situ SCC type AK I or II. This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory. 4. Willingness to comply with the obligations of the study
|
|
E.4 | Principal exclusion criteria |
A patient is ineligible and must not enter the study if any of the following criteria is met: Safety concerns: 1. History of allergic reaction to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients. 2. Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner. Lack of suitability for the study: 3. Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns. 4. Persisting AK lesion following topical treatment with imiquimod or diclofenac in the STA present at screening visit. 5. Presence of any histologically confirmed skin tumour in the STA: in situ SCC type AK III, Bowen’s disease, invasive squamous cell carcinoma, basal cell carcinoma or other malignant tumours. 6. Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis). 7. Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema). 8. Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation. 9. Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation. 10. Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment. 11. History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy). 12. History of any malignant skin tumour actively treated by chemotherapy or retinoids. 13. History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years. 14. Mentally incapacitated patient. 15. Present or history of drug or alcohol abuse within the last 3 years. Administrative reasons: 16. Exposure to an investigational product within the last 3 months. 17. Lack of ability or willingness to give informed consent. 18. Age below 18 years. 19. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol. 20. Anticipated non-availability for study visits/procedures. 21. Vulnerable subjects (such as persons kept in detention).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable ("endpoint") is the (patient) recurrence rate with respect to the STA. A patient is classified as recurrent when cleared at Week 20 and having clinically at least one evident AK lesion in the STA later on. |
|
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |