Status:
COMPLETED
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
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Photosensitivity Disorders
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00204542
Start Date
June 1 2005
End Date
December 1 2010
Last Update
August 19 2011
Active Locations (4)
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1
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
Tübingen, Baden-Wurttemberg, Germany, 72076
2
Klinik fuer Dermatologie, Venerologie und Allergologie der Charite
Berlin, Germany, 10117
3
Dept. of Dermatology
Freiburg im Breisgau, Germany, 79104
4
Praxis Priv.-Doz. Dr. med. Dirschka
Wuppertal, Germany