Observational (non-interventional), follow-up trial assessing long-term local tolerability and efficacy (recurrence rate) of resiquimod gel in patients treated for actinic keratosis.

• Conditions: Actinic Keratosis; MedDRA version: 14.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-003589-42-DE
• Lead Sponsor: Spirig Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-19
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified