Three-armed, Randomized, Double-blind Dose-finding Trial on Efficiency and Safety of AK 3012 in 3 Different Concentrations in Patients With Actinic Keratosis Olsen Grade I/II
Inclusion Criteria:
- Age: ≥ 18 years
- Gender: male and female
- Actinic Keratosis (Olsen grade I/II)
- at least 5 actinic keratoses on the scalp, forehead, face, extremities, and/ or
decollete
- no treatment of the actinic keratoses within the previous 3 months before inclusion
in the study
- histologic confirmation of the diagnosis actinic keratosis by biopsy
- good general condition
- normal laboratory values (creatinine, urea, Glutamate-Oxalacetate Transaminase
(GOT),Glutamate-Pyruvate Transaminase (GPT), gamma-glutamyl transferase (GGT),
Lactate dehydrogenase (LDH)) and blood count at study start not higher than 1.5 x
upper norm limit
- Female patients must be tested negative for pregnancy before inclusion in the trial.
During the trial, female patients have to apply a generally accepted form of birth
control (i.e. oral estrogen- and gestagen containing contraceptives; estrogen
containing skin plaster/ tape, hormone implant, hormone contraceptive coil,
sterilisation; sexual abstinence) or being post-menopausal for at least 2 years.
- Willing and able to participate in the screening and all trial specific procedures in
compliance with the protocol
- Signed written informed consent
Exclusion Criteria:
- Known allergy against nonsteroidal antiphlogistics and/ or against excipients of the
investigational medicinal product
- Presence of immunosuppression
- Treatment with 5-fluorouracil, cyclosporine, retinoids, glycolic acid, imiquimod,
trichloroacetic acid during the trial or 12 weeks before inclusion in the trial
- Continuous treatment with nonsteroidal antiphlogistics
- Planned treatment with photodynamic therapy during participation in the trial
- Pregnancy or lactation
- Participation in another clinical trial within 3 months before inclusion in the
current trial