Overview

This trial is active, not recruiting.

Condition actinic keratosis
Treatments eryfotona ak-nmsc® cream, sunscreen spf 50+
Phase phase 4
Sponsor ISDIN
Start date July 2012
End date January 2014
Trial size 50 participants
Trial identifier NCT01656226, ISD-FPT-01-2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
eryfotona ak-nmsc® cream
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.
(Other)
sunscreen spf 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.

Primary Outcomes

Measure
Percentage of patients with partial clearance of AK lesions
time frame: 6 months

Secondary Outcomes

Measure
Percentage of patients with clearance and improvement of AK lesions
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)
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
time frame: 6 months
Percentage of patients with changes in the Investigator Global Improvement Index
time frame: 6 months
Percentage of patients with changes in Baseline Severity Index (BSI)
time frame: 6 months
Percentage of patients with improvement in the target AK lesion by using RCM score.
time frame: 6 months
Percentage of patients with improvement in the "cancerization filed" by RCM score
time frame: 6 months
Percentage of patients compliant to treatment
time frame: 6 months
Percentage of patients which report satisfaction to local tolerability
time frame: 6 months
Number of patients with AEs and local AEs (skin reactions)
time frame: 6 months
Percentage of patients which report satisfaction to treatment
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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.
Principal investigator Dr. Giuseppe Argenziano, , MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by ISDIN.