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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
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.
Recurrence with respect to the study treatment area 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
Time frame: week 20 until month 12
Time to recurrence
Time frame: 3 years
Long-term outcome with respect to development of SCC (in situ and/or invasive)
Time frame: 3 years
Need of rescue treatment
Time frame: 3 years
Haematological changes
Time frame: 20 weeks
Cosmetic outcome.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Feldkirch, Department for Dermatology and Venereology
Feldkirch, Austria
Medical University Graz, University Clinic for Dermatology and Venereology
Graz, Austria
Medical University Innsbruck, University Clinic for Dermatology and Venereology
Innsbruck, Austria
Medical University Vienna, Department for General Dermatology
Vienna, Austria
CHU St Jacques, Department for Dermatology
Besançon, France
Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor
Marseille, France
CHU Nice - Hospital Archet 2, Department for Dermatology
Nice, France
Hospital Saint-Louis, Derpartment for Dermatology
Paris, France
Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology
Pierre-Bénite, France
Licca Clinical Research Institute
Augsburg, Germany
...and 16 more locations