Trial Information
Prospective, Randomized, Partly Blinded, in Part Placebo-controlled, Multicenter, Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Number of patients with complete clinical clearance in the treated area at the end of trial
Outcome Time Frame:
8 weeks after a maximal treatment period of 8 weeks
Safety Issue:
No
Principal Investigator
Lars E French, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Clinic of Dermatology, Zurich
Authority:
Switzerland: Ethikkommission
Study ID:
SP848-AK-1101
NCT ID:
NCT01583816
Start Date:
May 2012
Completion Date:
March 2014
Related Keywords:
- Actinic Keratosis
- Actinic Keratosis
- Resiquimod
- Keratosis
- Keratosis, Actinic