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

ISDIN

Status and phase: Unknown; Phase 4

Conditions: Actinic Keratosis

Treatments: Other: Sunscreen SPF 50+; Device: Eryfotona AK-NMSC® cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01656226

ISD-FPT-01-2012

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Eryfotona AK-NMSC® cream

Experimental group

Treatment:

Device: Eryfotona AK-NMSC® cream

Sunscreen SPF 50+

Other group

Treatment:

Other: Sunscreen SPF 50+