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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.


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of patients with partial clearance of AK lesions

Outcome Description:

Comparison between treatment groups at the end of the treatment period

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Dr. Giuseppe Argenziano, , MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy

Authority:

Italy: Ethics Committee

Study ID:

ISD-FPT-01-2012

NCT ID:

NCT01656226

Start Date:

July 2012

Completion Date:

April 2013

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • AK
  • Keratosis
  • Keratosis, Actinic

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