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

 -  Signed informed consent.

 -  Participation in the previous clinical trial SP848-AK-1101.

 -  Patient with complete clinical clearance (i.e. no previously existing AK-lesion
 present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the
 trial prematurely.

 Exclusion Criteria:

 -  Evidence of unstable or uncontrolled clinically significant medical conditions as
 determined by the investigator (e.g., cardiovascular, immunological, hematologic,
 hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal
 abnormalities or diseases).

 -  Evidence of systemic cancer.

 -  Dermatological disease or condition in the former treatment or surrounding area that
 might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed
 by the investigator.