Observational Trial Assessing Long-term Local Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01806961
First received: March 6, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition
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:
  • Occurrence of new AK-lesions within the former treatment area [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • 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: Yes ]

Enrollment: 16
Study Start Date: February 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Patients ex. Arm 1 SP848-AK-1101 trial
Group 2
Patients ex. Arm 2 SP848-AK-1101 trial
Group 3
Patients ex. Arm 3 SP848-AK-1101 trial
Group 4
Patients ex. Arm 4 SP848-AK-1101 trial
Group 5
Patients ex. Arm 5 SP848-AK-1101 trial

  Eligibility

Ages Eligible for Study:   18 Years and older
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806961

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

No publications provided

Responsible Party: Spirig Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01806961     History of Changes
Other Study ID Numbers: SP848-AKEx-1209
Study First Received: March 6, 2013
Last Updated: October 24, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014