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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)

Trial Profile

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 of Trial: Phase III

Latest Information Update: 06 Apr 2017

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At a glance

  • Drugs Fluorouracil/salicylic-acid (Primary)
  • Indications Actinic keratosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Almirall Hermal GmbH; Almirall S.A.
  • Most Recent Events

    • 01 Mar 2017 Results (n=163) published in the Dermatology and Therapy
    • 05 Sep 2016 Primary endpoint has been met. (Percentage of patients with complete clinical clearance (CCC) of AK lesions in the treatment field at 8 weeks post last treatment [Timepoint: 8 weeks post last treatment ])
    • 05 Sep 2016 According to an Almirall media release, results from this study have been presented at the 16th World Congress on Cancers of the Skin & 12th Congress of the European Association of Dermato Oncology (EADO).
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