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

Conditions: This study will compare the long term effects of Aldara® and Solaraze® of the actinic keratoses on the face or scalp. Actinic keratoses (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 version: 14.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2007-004884-24-AT

Lead Sponsor: MEDA Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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 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 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:
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 190

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. 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. Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.
7. 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.
8. Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
9. Any dermatological disease or condition in the STA that causes
difficulty with examination (e.g. eczema).
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 having metastasised or where metastasis could be expected.
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).

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 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.;Secondary Objective: Secondary objectives include the time to recurrence, long-term outcome with respect to development of invasive SCC (squamous cell carcinoma) (in situ and/or invasive), need of rescue treatment, haematological changes, and cosmetic outcome.;Primary end point(s): The primary efficacy variable (endpoint) is the (patient) recurrence<br>rate with respect to the STA. A patient is classified as recurrent when cleared at Week 20 and having later on at least one clinically diagnosed AK lesion in the STA.;Timepoint(s) of evaluation of this end point: 20 weeks after start of treatment cycle until month 12.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Include the time to recurrence, long-term outcome with respect to<br>development of SCC (in situ and/or invasive), need of rescue treatment, haematological changes, and cosmetic outcome, and adverse events.;Timepoint(s) of evaluation of this end point: Depending on the endpoint either 20 weeks after start of each treatment cycle, at least half-yearly or at any visit until month 36.