Comparison of the Efficacy and Tolerability of Solaraze for 3 vs. 6 Months in Patients With Mild to Moderate Actinic Keratosis Located at the Face and Head
Inclusion Criteria:
- Visible and histologically proven actinic keratosis
- Prepared and able to give written informed consent
- ≥ 18 -80 years of age
- Prepared and comply with all study requirements, including the following: application
of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy,
treatment, posttreatment, and follow-up period
- Pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic
keratosis diagnosis
Exclusion Criteria:
- Data of clinically significant, unstable, cardiovascular or haematologic, hepatic,
neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or
diseases
- Known allergies to any excipient in the study drug
- Any dermatological disease and/or condition in the treatment or surrounding area (3
cm distances from treatment area) that may be exacerbated by treatment with
diclofenac or cause difficulty with examination
- Active chemical dependency or alcoholism, as assessed by the investigator
- Currently participating in another clinical study or have completed another clinical
study with an investigational drug within the past 30 days
- Received topical treatment at the treatment area with imiquimod or 5-FU within a time
period of 1 month
- Invasive tumours within the treatment area, e.g. merkel cell carcinoma, squamous cell
carcinoma, basal cell carcinoma, the latter is accepted if completely surgically
removed