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

Spirig Pharma Ltd.16 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Actinic Keratosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Hauttumorcentrum Charité (HTCC)

Berlin, Germany

Medizinisches Zentrum Bonn - Friedensplatz

Bonn, Germany

Hautzentrum

Düsseldorf, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

Outcomes

Primary Outcomes

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.

Time frame: at 6 and 12 months

Secondary Outcomes

Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)

clinical examination

Time frame: at 6 and 12 months

Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area

recording of adverse events

Time frame: at 6 and 12 months

Data from ClinicalTrials.gov

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