Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spirig Pharma Ltd.

Criteria

Inclusion Criteria:

• Signed informed consent

• Male or nonpregnant, nonlactating female, ≥18 years

• A minimum of 2 clinically diagnosed AK-lesions within a defined area (25 cm2 contiguous treatment area). One AK-lesion must have a diameter of at least 6 mm (indicator lesion)

• AK-lesions on balding scalp, forehead or face

Exclusion Criteria:

• Known allergy or hypersensitivity to any of the trial gel ingredients

• Dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments

• Evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer