The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Percentage of patients with partial clearance of AK lesions
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
Percentage of patients with clearance and improvement of AK lesions
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy)
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
Percentage of patients with changes in the Investigator Global Improvement Index
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
Percentage of patients with changes in Baseline Severity Index (BSI)
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
Percentage of patients with improvement in the target AK lesion by using RCM score.
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
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Percentage of patients with improvement in the "cancerization filed" by RCM score
Comparison between treatment groups at the end of the treatment period Validation of a new RCM score
Time frame: 6 months
Percentage of patients compliant to treatment
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months
Percentage of patients which report satisfaction to local tolerability
Comparison between treatment groups over time and at the end of the treatment period
Time frame: 6 months
Number of patients with AEs and local AEs (skin reactions)
Comparison between treatment groups over time and at the end of the treatment period
Time frame: 6 months
Percentage of patients which report satisfaction to treatment
Comparison between treatment groups at the end of the treatment period
Time frame: 6 months