Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses
- Registration Number
- NCT00777127
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG
- Brief Summary
This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 258
- 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 (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.
- Willingness to comply with the obligations of the study.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Imiquimod Aldara 5% Cream 2 Diclofenac Solaraze 3% Gel
- Primary Outcome Measures
Name Time Method Recurrence with respect to the study treatment area until month 12 week 20 until month 12 A patient is classified as recurrent when cleared at Visit Week 20 and having later on at least one clinically diagnosed AK lesion in the study treatment area
- Secondary Outcome Measures
Name Time Method Haematological changes 20 weeks Cosmetic outcome. 3 years Time to recurrence 3 years Long-term outcome with respect to development of SCC (in situ and/or invasive) 3 years Need of rescue treatment 3 years
Trial Locations
- Locations (26)
Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor
🇫🇷Marseille, France
CHU St Jacques, Department for Dermatology
🇫🇷Besancon Cedex, France
Derma Center Vechta
🇩🇪Vechta, Germany
Medical practice
🇩🇪Düsseldorf, Germany
Hospital Feldkirch, Department for Dermatology and Venereology
🇦🇹Feldkirch, Austria
Medical University Graz, University Clinic for Dermatology and Venereology
🇦🇹Graz, Austria
University Clinic Düsseldorf, Clinic for Dermatology
🇩🇪Düsseldorf, Germany
University Clinic Münster, Clinic and Polyclinic for Skin Diseases
🇩🇪Münster, Germany
Medical Practice Dominicus / Bockhorst
🇩🇪Duelmen, Germany
CHU Nice - Hospital Archet 2, Department for Dermatology
🇫🇷Nice, France
Licca Clinical Research Institute
🇩🇪Augsburg, Germany
Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology
🇫🇷Pierre Benite, France
Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology
🇩🇪Frankfurt am Main, Germany
Medical University Innsbruck, University Clinic for Dermatology and Venereology
🇦🇹Innsbruck, Austria
Hospital Saint-Louis, Derpartment for Dermatology
🇫🇷Paris, France
Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology
🇩🇪Berlin, Germany
Medical practice for Dermatology and Venerology
🇩🇪Wuppertal, Germany
Medical University Vienna, Department for General Dermatology
🇦🇹Vienna, Austria
SCiderm GmbH
🇩🇪Hamburg, Germany
Medical Practice
🇩🇪Hannover, Germany
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology
🇩🇪Magdeburg, Germany
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology
🇩🇪Kiel, Germany
Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center
🇩🇪Mainz, Germany
Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics
🇩🇪Mönchengladbach, Germany
Clinic University Regensburg, Clinic and Polyclinic for Dermatology
🇩🇪Regensburg, Germany
Centrovital
🇩🇪Witten, Germany