Actinic Keratosis Studies

Sponsor: Athenex PI: SAF Phase: 3
A Phase III, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects with Actinic Keratosis on the Face or Scalp KX01-AK003
October 2017- Present

Sponsor: Therapeutics Inc PI: KWD Phase: 3
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of a Generic Ingenol Mebutate Gel, 0.015% and Picato Gel, 0.015% in Subjects with Actinic Keratosis on the Face or Scalp 094-8152-301
July 2016 to May 2017

Sponsor: LEO Pharma A/S PI: SAF Phase: 3
Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest – LP0105-1032
May 2015 to April 2017

Sponsor: Perrigo UK FINCO Limited Par. PI: Phase: 3
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo UK Finco Ingenol Mebutate Topical Gel 0.015% to Leo Pharma Inc. Picato® Topical Gel 0.015% (Ingenol Mebutate Topical Gel 0.015%), and Both Active Treatments to a Vehicle Control in the Treatment of Actinic Keratosis on the Head Region (Face or Scalp) – PRG-NY-14-019
March 2015 to December 2015

Sponsor: LEO Pharma A/S PI: Phase: 3
Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively – LP0084-1148
February 2015 to September 2015

Sponsor: Actavis Mid Atlantic, LLC PI: Phase: 3
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of a Generic Ingenol Mebutate Gel, 0.05% and Picato® Gel, 0.05% in Subjects with Actinic Keratosis on the Trunk or Extremities – 094-8151-301
January 2015 to January 2016

Sponsor: LEO Pharma A/S PI: Phase: 2
Safety and efficacy of escalating doses of ingenol mebutate once daily for two or three consecutive days when used on full face, full balding scalp or approximately 250 cm2 on the chest in subjects with actinic keratosis Part 1: A Phase 1, multicentre, open-label, dose escalation 2-week trial Part 2: A Phase 2, multicentre, randomised, double-blind, parallel group, vehicle-controlled, 8-week trial – LP0105-1012
December 2013 to August 2014

Sponsor: Actavis Elizabeth LLC PI: Phase:
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 2.5% and Zyclara™ (imiquimod) Cream 2.5% in Subjects with Actinic Keratoses – 094-3153-301
October 2013 to June 2014

Sponsor: Peplin Operations PI: Phase:
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratoses on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 – PEP005-030
August 2009 to January 2011


Sponsor: Peplin Operations PI: Phase: 2

A Phase II, Multi-Center, Randomized, Parallel Group, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients with Actinic Keratoses on Non-Head Locations – PEP005-028
July 2009 to January 2011

 

Sponsor: Peplin Operations PI: Phase: 3
A Phase III Multi-Center, Randomized, Parallel Group, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.15% in Patients with Actinic Keratoses on the Head (Face or Scalp) – PEP005-016
June 2009 to January 2011


Sponsor: Peplin Operations PI: Phase: 3

A Phase III, Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities) – PEP005-028
June 2009 to January 2011

Sponsor: Graceway Pharmaceuticals, LLC PI: Phase: 4
A Phase IV, Open-Label Safety and Pharmacokinetic Study of Aldara(Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis
September 2005 to June 2007

Sponsor: 3M PI: Phase: 3B
A Phase IIIb, Open-Label Effectiveness and Safety Study of Imiquimod 5% Topical Cream in the Treatment of Actinic Keratosis.
April 2004 to August 2004