NCT01656226

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

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ISDIN · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-08-02
• Last updated: 2013-10-11

Locations

1 site across 1 country: Italy