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

Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.

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.

Study Overview

• Status: Terminated
• Conditions: Actinic Keratosis

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Hauttumorcentrum Charité (HTCC)
  • Bonn, Germany
    • Medizinisches Zentrum Bonn - Friedensplatz
  • Düsseldorf, Germany
    • Hautzentrum
  • Minden, Germany
    • Johannes Wesling Klinikum Minden
  • Recklinghausen, Germany
    • KLINIKUM VEST GmbH Knappschaftskrankenhaus
• Switzerland
  • Basel, Switzerland
    • Universitätsspital Basel
  • Bern, Switzerland
    • Inselspital
  • St. Gallen, Switzerland
    • Kantonsspital St.Gallen
  • Zurich, Switzerland
    • UniversitaetsSpital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
clearance at end of trial SP848-AK-1101; no trial medication during this follow-up trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Spirig Pharma Ltd.
• Investigators: Principal Investigator: Lars E French, MD, University Clinic of Dermatology, Zurich

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 7, 2013

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: June 21, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: SP848-AKEx-1209