Overview

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

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Almirall, S.A.
Collaborator:
Almirall Hermal GmbH
Treatments:
Fluorouracil
Pharmaceutical Solutions
Salicylates
Salicylic Acid