Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Double-blind Parallel-group Study to Evaluate the Long-term Effects of Eryfotona AK-NMSC® Cream in the Treatment of Cancerization Field in Patients With Actinic Keratosis.

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Device: Eryfotona AK-NMSC® cream
* Other: Sunscreen SPF 50+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current diagnosis of AK, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead); Female or male >18 years of age; Skin type I or II according to Fitzpatrick; Patient has confirmed his/her willingness to participate in this study;. Exclusion Criteria: Topical drug therapy for AK within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected AK area during the previous month; Suitable for surgical, photodynamic or any other topical treatment in the next 6 months; Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer; Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm; Immunosuppression or current treatment for cancer; Clinically unstable medical condition; High risk group for HIV infection or presentation of other infectious diseases Presentation of contact allergies or allergies to compounds of the test substances; Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day); Psychiatric disease that may interfere with follow up of study procedures; Participation in other clinical trials up to 30 days prior to day 1 of the study Prior treatment with study medication in the area to be treated; Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eryfotona AK-NMSC® cream<br> | Device: Eryfotona AK-NMSC® cream<br>* 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.<br>|
| Other: Sunscreen SPF 50+<br> | Other: Sunscreen SPF 50+<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with partial clearance of AK lesions | Comparison between treatment groups at the end of the treatment period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with clearance and improvement of AK lesions | Comparison between treatment groups at the end of the treatment period | 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 | 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 | 6 months | 
| Percentage of patients with changes in the Investigator Global Improvement Index | Comparison between treatment groups at the end of the treatment period | 6 months | 
| Percentage of patients with changes in Baseline Severity Index (BSI) | Comparison between treatment groups at the end of the treatment period | 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 | 6 months | 
| 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 | 6 months | 
| Percentage of patients compliant to treatment | Comparison between treatment groups at the end of the treatment period | 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 | 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 | 6 months | 
| Percentage of patients which report satisfaction to treatment | Comparison between treatment groups at the end of the treatment period | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis, AK