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

Phase 4

• Conditions: Actinic Keratosis
• Interventions: Device: Eryfotona AK-NMSC® cream; Other: Sunscreen SPF 50+

• Registration Number: NCT01656226
• Lead Sponsor: ISDIN

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-24
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-02
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. 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);
2. Female or male >18 years of age;
3. Skin type I or II according to Fitzpatrick;
4. Patient has confirmed his/her willingness to participate in this study;.

Exclusion Criteria

1. 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;
2. Suitable for surgical, photodynamic or any other topical treatment in the next 6 months;
3. Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer;
4. Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm;
5. Immunosuppression or current treatment for cancer;
6. Clinically unstable medical condition;
7. High risk group for HIV infection or presentation of other infectious diseases
8. Presentation of contact allergies or allergies to compounds of the test substances;
9. Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day);
10. Psychiatric disease that may interfere with follow up of study procedures;
11. Participation in other clinical trials up to 30 days prior to day 1 of the study
12. Prior treatment with study medication in the area to be treated;
13. Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eryfotona AK-NMSC® cream	Eryfotona AK-NMSC® cream	-
Sunscreen SPF 50+	Sunscreen SPF 50+	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with partial clearance of AK lesions	6 months	Comparison between treatment groups at the end of the treatment period

Secondary Outcome Measures

Name	Time	Method
Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy)	6 months	Comparison between treatment groups at the end of the treatment period
Percentage of patients with changes in Baseline Severity Index (BSI)	6 months	Comparison between treatment groups at the end of the treatment period
Number of patients with AEs and local AEs (skin reactions)	6 months	Comparison between treatment groups over time and at the end of the treatment period
Percentage of patients with clearance and improvement of AK lesions	6 months	Comparison between treatment groups at the end of the treatment period
Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs	6 months	Comparison between treatment groups at the end of the treatment period
Percentage of patients with improvement in the target AK lesion by using RCM score.	6 months	Comparison between treatment groups at the end of the treatment period
Percentage of patients with improvement in the "cancerization filed" by RCM score	6 months	Comparison between treatment groups at the end of the treatment period Validation of a new RCM score
Percentage of patients compliant to treatment	6 months	Comparison between treatment groups at the end of the treatment period
Percentage of patients which report satisfaction to local tolerability	6 months	Comparison between treatment groups over time and at the end of the treatment period
Percentage of patients which report satisfaction to treatment	6 months	Comparison between treatment groups at the end of the treatment period
Percentage of patients with changes in the Investigator Global Improvement Index	6 months	Comparison between treatment groups at the end of the treatment period

Trial Locations

Locations (1)

Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy