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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eryfotona AK-NMSC® cream | Experimental |
| |
| Sunscreen SPF 50+ | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eryfotona AK-NMSC® cream | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Giuseppe Argenziano,, MD, PhD | Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova | Reggio Emilia | Italy |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| Sunscreen SPF 50+ | Other | 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. |
|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |