Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Actinic Keratosis
- Sponsor
- Spirig Pharma Ltd.
- Enrollment
- 16
- Locations
- 9
- Primary Endpoint
- Determine the Recurrence Rate of AK-lesions
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent.
- •Participation in the previous clinical trial SP848-AK-
- •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.
Outcomes
Primary Outcomes
Determine the Recurrence Rate of AK-lesions
Time Frame: at 6 and 12 months
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.
Secondary Outcomes
- Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area(at 6 and 12 months)
- Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)(at 6 and 12 months)