Clinical trial NCT01656226: Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
AK
Lead sponsor: ISDIN
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with partial clearance of AK lesions
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of patients with clearance and improvement of AK lesions
timeFrame: 6 months
measure: Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy)
timeFrame: 6 months
measure: Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs
timeFrame: 6 months
measure: Percentage of patients with changes in the Investigator Global Improvement Index
timeFrame: 6 months
measure: Percentage of patients with changes in Baseline Severity Index (BSI)
timeFrame: 6 months
measure: Percentage of patients with improvement in the target AK lesion by using RCM score.
timeFrame: 6 months
measure: Percentage of patients with improvement in the "cancerization filed" by RCM score
timeFrame: 6 months
measure: Percentage of patients compliant to treatment
timeFrame: 6 months
measure: Percentage of patients which report satisfaction to local tolerability
timeFrame: 6 months
measure: Number of patients with AEs and local AEs (skin reactions)
timeFrame: 6 months
measure: Percentage of patients which report satisfaction to treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova
Study officials:
affiliation: Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy
name: Dr. Giuseppe Argenziano,, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: