drugset / Trial / NCT02354391

Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis

NCT02354391

Phase 2 Unknown 20 enrolled Pacific Dermaesthetics LEO Pharma · collab
NaSingle-groupOpen-labelTreatment

Summary

The objective of this study is to determine the efficacy, safety, and patient satisfaction of pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test group and the control group. Each patient will have four distinct treatment areas of 25cm2 on the scalp, and/or scalp and face. Three of the treatment areas will receive Picato® 0.015% gel, MAL PDT, or Picato® 0.015% and MAL PDT combined. One area will serve as a control and will receive none of the treatments.

Timeline

Start
2015-01
Primary completion
2019-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ingenol mebutate Small molecule 0.015 % Topical
Subject methyl aminolevulinate Small molecule

Indications