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

Terminated

• Conditions: Actinic Keratosis

• Registration Number: NCT01806961
• Lead Sponsor: Spirig Pharma Ltd.

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Results First Submitted: 2015-12-14
• Results First Submitted QC: 2015-12-14
• Results First Posted: 2016-01-20
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the Recurrence Rate of AK-lesions	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 Outcome Measures

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

Trial Locations

Locations (9)

Hauttumorcentrum Charité (HTCC); 🇩🇪 Berlin, Germany

Medizinisches Zentrum Bonn - Friedensplatz; 🇩🇪 Bonn, Germany

Hautzentrum; 🇩🇪 Düsseldorf, Germany

Inselspital; 🇨🇭 Bern, Switzerland

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

KLINIKUM VEST GmbH Knappschaftskrankenhaus; 🇩🇪 Recklinghausen, Germany

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St. Gallen, Switzerland

Universitaetsspital Zurich; 🇨🇭 Zurich, Switzerland