Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.
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|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|
|Primary Completion Date :||June 2013|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|