Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.
|ClinicalTrials.gov Identifier: NCT01806961|
Recruitment Status : Terminated (sponsor decision)
First Posted : March 7, 2013
Results First Posted : January 20, 2016
Last Update Posted : August 3, 2016
|Condition or disease|
• Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|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.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||September 2013|
clearance at end of trial SP848-AK-1101
no trial medication during this follow-up trial
- 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.
- Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes) [ Time Frame: at 6 and 12 months ]clinical examination
- Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area [ Time Frame: at 6 and 12 months ]recording of adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806961
|Hauttumorcentrum Charité (HTCC)|
|Medizinisches Zentrum Bonn - Friedensplatz|
|Johannes Wesling Klinikum Minden|
|KLINIKUM VEST GmbH Knappschaftskrankenhaus|
|St. Gallen, Switzerland|
|Principal Investigator:||Lars E French, MD||University Clinic of Dermatology, Zurich|