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 (Imiquimod) or Solaraze® 3% gel (Diclofenac) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT.
Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks.
Medical University Graz, University Clinic for Dermatology and Venerology Graz
Graz, Austria
Medical Practice
Maria Enzersdorf, Austria
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 3271).
Time frame: 3 years
Recurrence rate
Time frame: 3 years
Time to recurrence
Time frame: 3 years
Need of rescue treatment
Time frame: 3 year
Cosmetic outcome
Cosmetic outcome assessed by patient and investigator on a verbal rating scale.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical University Vienna, Department for General Dermatology
Vienna, Austria
Medical Supply Center
Augsburg, Germany
Licca Clinical Research Institute, Clinic for Dermatolgy and Surgery
Augsburg, Germany
Medical Practice
Berlin, Germany
Medical Practice
Dülmen, Germany
Medical Practice
Germering, Germany
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venerology
Magdeburg, Germany
Medical Practice
Mahlow, Germany
...and 7 more locations