ong-term effects of Aldara® 5% cream compared toSolaraze® 3% gel in the treatment of actinic keratoseson the face or scalp.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

1. Immunocompetent patient.
2. 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.
3. A positive histological finding for AK grade I or II (see Section 7.1.1.2). 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

1. History of hypersensitivity 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 excessive hyperkeratosis as seen in cutaneous horns.
4. 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.
5. Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
6. 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.
7. Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
8. Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
9. 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.
10. History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
11. History of any malignant skin tumour having metastasised or in which metastasis within the study period is likely.
12. 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.
13. Mentally incapacitated patient.
14. Present or history of drug or alcohol abuse within the last 3 years.
Administrative reasons:
15. Exposure to an investigational product within the last 3 months.
16. Lack of ability or willingness to give informed consent.
17. Age below 18 years.
18. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
19. Anticipated non-availability for study visits/procedures.
20. Vulnerable subjects (such as persons kept in detention).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine the long-term outcome with respect to the risk of progression to SCC (in situ and/or invasive) of treatment with Aldara® 5% cream (IMIQ) and Solaraze® 3% gel (DIC) with increased precision (meta-analysis with study X-03016-3271).;Secondary Objective: Secondary objectives include recurrence rates, the time to recurrence, need of rescue treatment, and cosmetic outcome.;Primary end point(s): The histological finding of an in situ SCC or an invasive SCC after start of treatment will be considered as histological progression”, which is the primary efficacy variable (”endpoint”).;Timepoint(s) of evaluation of this end point: 20 weeks after start of each treatment cycle until month 36.

Secondary Outcome Measures

Name	Time	Method

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