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

Actinic Keratosis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01806961
• Other study ID #: SP848-AKEx-1209
• Status: Terminated
• Phase: N/A
• First received: March 6, 2013
• Last updated: December 14, 2015
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: December 2015
• Source: Spirig Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: SwissmedicGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Locations

Country	Name	City	State
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
Switzerland	Universitätsspital Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	Kantonsspital St.Gallen	St. Gallen
Switzerland	Universitaetsspital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Spirig Pharma Ltd.

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Occurrence of New AK-lesions Within the Former Treatment Area		at 6 and 12 months	No
Secondary	Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area		at 6 and 12 months	Yes