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

NCT01656226 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-10-11

No results posted yet for this study

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.

Conditions

  • Actinic Keratosis

Interventions

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.

Sponsors & Collaborators

  • ISDIN

    lead INDUSTRY

Principal Investigators

  • Dr. Giuseppe Argenziano,, MD, PhD · Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656226 on ClinicalTrials.gov