NCT02289768

Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses

Multicentre, Randomized, Parallel, Double-Blind, Vehicle Controlled Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In The Field-Directed Treatment Of Actinic Keratoses Grade I To II (Field Cancerization)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this vehicle-controlled study is to determine the efficacy and safety of a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the field-directed treatment of grade I-II actinic keratosis, when it is applied to the affected area once daily for 12 weeks. A secondary objective of this study is to evaluate the efficacy of Actikerall® solution on subclinical actinic keratosis lesions in a subset of patients.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	5-fluorouracil/salicylic acid
DRUG	Vehicle

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-11-13
• Last updated: 2016-08-05

Locations

14 sites across 2 countries: Germany, United Kingdom