Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

Exclusion Criteria

• •Safety concerns:
• •History of allergic reaction to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.
• •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:
• •Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
• •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.
• •Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
• •Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.
• •Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
• •Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
• •Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
• •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.
• •History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
• •History of any malignant skin tumour having metastasised or where metastasis could be expected.
• •History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.
• •Mentally incapacitated patient.
• •Present or history of drug or alcohol abuse within the last 3 years.
• •Administrative reasons:
• •Exposure to an investigational product within the last 3 months.
• •Lack of ability or willingness to give informed consent.
• •Age below 18 years.
• •Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
• •Anticipated non-availability for study visits/procedures.
• •Vulnerable subjects (such as persons kept in detention).