Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head
- Registration Number
- NCT00204542
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses.
Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 418
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Diclofenac Solaraze(R) 2x/day for 3 months B Diclofenac Solaraze(R) 2x/day for 6 months
- Primary Outcome Measures
Name Time Method Histologically controlled complete clearance of the actinic keratosis 6 weeks after end of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
🇩🇪Tübingen, BW, Germany
Klinik fuer Dermatologie, Venerologie und Allergologie der Charite
🇩🇪Berlin, Germany
Dept. of Dermatology
🇩🇪Freiburg, Germany
Praxis Priv.-Doz. Dr. med. Dirschka
🇩🇪Wuppertal, Germany
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8🇩🇪Tübingen, BW, Germany