RANDOMIZED, MULTICENTRE OPEN LABEL STUDY TO COMPARE THE EFFICACY AND TOLERABILITY OF SOLARAZE® FOR 3 MONTHS VERSUS 6 MONTHS IN PATIENTS WITH MILD TO MODERATE ACTINIC KERATOSIS LOCATED AT THE FACE AND HEAD - ADO-Solaraze-AK-3-6
- Conditions
- Mild to moderate actinic keratoses located at the face and head
- Registration Number
- EUCTR2004-002761-21-DE
- Lead Sponsor
- niversity Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 418
visible and histologically proven AK
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
AK-diagnosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases. remind: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis will be allowed to enter the study
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, eg: merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method