Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp With Respect to the Risk of Progression to In-situ and Invasive Squamous Cell Carcinoma
To be eligible, a patient must comply with all of the following criteria:
- Immunocompetent patient.
- A study treatment area 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.
- A positive histological finding for AK grade 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
- Willingness to comply with the obligations of the study.
A patient is ineligible and must not enter the study if any of the following criteria is
- History of hypersensitivity to imiquimod, diclofenac, acetyl salicylic acid, other
non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant
- 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 excessive hyperkeratosis as seen in
- 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.
- 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
- 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 in which metastasis
within the study period is likely.
- History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal,
haematological, endocrine, metabolic, mental, neurological, or other disease within
the last two years which might hinder regular treatment and supervision and might
lead to premature withdrawal from the study.
- Mentally incapacitated patient.
- Present or history of drug or alcohol abuse within the last 3 years.
- 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).