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

This study has been terminated.
(sponsor decision)
Information provided by (Responsible Party):
Spirig Pharma Ltd. Identifier:
First received: March 6, 2013
Last updated: June 21, 2016
Last verified: May 2016
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.

Actinic Keratosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

Further study details as provided by Spirig Pharma Ltd.:

Primary Outcome Measures:
  • Determine the Recurrence Rate of AK-lesions [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
    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:
  • Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
    clinical examination

  • Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
    recording of adverse events

Enrollment: 16
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
clearance at end of trial SP848-AK-1101
no trial medication during this follow-up trial

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01806961

Hauttumorcentrum Charité (HTCC)
Berlin, Germany
Medizinisches Zentrum Bonn - Friedensplatz
Bonn, Germany
Düsseldorf, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
KLINIKUM VEST GmbH Knappschaftskrankenhaus
Recklinghausen, Germany
Universitätsspital Basel
Basel, Switzerland
Bern, Switzerland
Kantonsspital St.Gallen
St. Gallen, Switzerland
Universitaetsspital Zurich
Zurich, Switzerland
Sponsors and Collaborators
Spirig Pharma Ltd.
Principal Investigator: Lars E French, MD University Clinic of Dermatology, Zurich
  More Information

Responsible Party: Spirig Pharma Ltd. Identifier: NCT01806961     History of Changes
Other Study ID Numbers: SP848-AKEx-1209 
Study First Received: March 6, 2013
Results First Received: December 14, 2015
Last Updated: June 21, 2016
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms processed this record on October 21, 2016