NCT01806961

Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.

Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Spirig Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.

Detailed description

Efficacy Evaluation: • Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions. Safety Evaluation: * Evaluation of adverse events (AEs) and serious adverse events (SAEs) * Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability). * Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101. * Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.

Conditions

• Actinic Keratosis

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-06-01
• Completion: 2013-09-01
• First posted: 2013-03-07
• Last updated: 2016-08-03
• Results posted: 2016-01-20

Locations

9 sites across 2 countries: Germany, Switzerland