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

Actinic Keratosis Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01656226
• Other study ID #: ISD-FPT-01-2012
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 24, 2012
• Last updated: October 10, 2013
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2012
• Source: ISDIN
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
ISDIN

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with partial clearance of AK lesions	Comparison between treatment groups at the end of the treatment period	6 months	No
Secondary	Percentage of patients with clearance and improvement of AK lesions	Comparison between treatment groups at the end of the treatment period	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of patients with changes in the Investigator Global Improvement Index	Comparison between treatment groups at the end of the treatment period	6 months	Yes
Secondary	Percentage of patients with changes in Baseline Severity Index (BSI)	Comparison between treatment groups at the end of the treatment period	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of patients compliant to treatment	Comparison between treatment groups at the end of the treatment period	6 months	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Percentage of patients which report satisfaction to treatment	Comparison between treatment groups at the end of the treatment period	6 months	No