Clinical trial NCT01806961: Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Actinic Keratosis
Lead sponsor: Spirig Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the Recurrence Rate of AK-lesions
timeFrame: at 6 and 12 months
Secondary outcomes:
measure: Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)
timeFrame: at 6 and 12 months
measure: Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area
timeFrame: at 6 and 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hauttumorcentrum Charité (HTCC)
city: Bonn
country: Germany
facility: Medizinisches Zentrum Bonn - Friedensplatz
city: Düsseldorf
country: Germany
facility: Hautzentrum
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Recklinghausen
country: Germany
facility: KLINIKUM VEST GmbH Knappschaftskrankenhaus
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zurich
country: Switzerland
facility: Universitaetsspital Zurich
Study officials:
affiliation: University Clinic of Dermatology, Zurich
name: Lars E French, MD
role: PRINCIPAL_INVESTIGATOR
References: