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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Actinic Keratosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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clearance at end of trial SP848-AK-1101

no trial medication during this follow-up trial

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No