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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Actinic Keratosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| clearance at end of trial SP848-AK-1101<br>no trial medication during this follow-up trial | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Recurrence Rate of AK-lesions | Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial. | at 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes) | clinical examination | at 6 and 12 months | 
| Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area | recording of adverse events | at 6 and 12 months |