Official Title: “Comparision 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”

Topical treatment of mild to moderate actinic keratosis located at 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 we evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice a day in face and head over 3 or 6 months of treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Solaraze® (Diclofenac sodium)
  • diclofenac topical 2x/day for 3 vs. 6 months
• Drug: dicofenac
  • 2x/day topical for 3 months
• Drug: diclofenac
  • 2x/day topical for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Solaraze(R) 2x/day for 3 months
• Active Comparator: B
  • Solaraze(R) 2x/day for 6 months

Primary Measures

• Histologically controlled complete clearance of the actinic keratosis
  • Time Frame: 6 weeks after end of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Tuebingen

Overall Clinical Trial Officials and Contacts

Claus Garbe, MD Principal Investigator Skin Cancer Program, Department of Dermatology, University Hospital Tübingen  

Overall Contact: Claus Garbe, MD ++49 7071 29 87110 claus.garbe@med.uni-tuebingen.de

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00204542

Study ID Number: ADO-Solaraze-AK-3-6

ClinicalTrials.gov Identifier: NCT00204542

Health Authority: Germany: Federal Institute for Drugs and Medical Devices