Status:
TERMINATED
Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.
Lead Sponsor:
Spirig Pharma Ltd.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01806961
Start Date
January 1 2013
End Date
September 1 2013
Last Update
August 3 2016
Active Locations (9)
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1
Hauttumorcentrum Charité (HTCC)
Berlin, Germany
2
Medizinisches Zentrum Bonn - Friedensplatz
Bonn, Germany
3
Hautzentrum
Düsseldorf, Germany
4
Johannes Wesling Klinikum Minden
Minden, Germany