NCT00204542

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Photosensitivity Disorders

Interventions

Type	Name	Description
DRUG	Diclofenac	Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
DRUG	Diclofenac	Solaraze® (Diclofenac sodium) 2x/day topical for 6 months

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-03-01
• Completion: 2010-12-01
• First posted: 2005-09-20
• Last updated: 2011-08-19

Locations

4 sites across 1 country: Germany