Actinic Keratosis Clinical Trial
Official title:
Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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