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

NCT ID: NCT01656226

Last Updated: 2013-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Actinic Keratosis

Keywords

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Actinic Keratosis AK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Eryfotona AK-NMSC® cream

Group Type EXPERIMENTAL

Eryfotona AK-NMSC® cream

Intervention Type DEVICE

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.

Sunscreen SPF 50+

Group Type OTHER

Sunscreen SPF 50+

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ISDIN

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Giuseppe Argenziano,, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ISD-FPT-01-2012

Identifier Type: -

Identifier Source: org_study_id