sponsor decision

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.

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.

7 months

No efficacy analysis was carried out since due to premature study termination (upon Sponsor's decision) no data was available for analysis