Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Key facts

Study ID

NCT02120456

Run by

LEO Pharma

People needed

224

Starts

2014-05-01

Expected to finish

2015-05-01

Last updated by the study team

2025-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
• Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

You may not qualify if…

• Location of the treatment area
• within 5 cm of an incompletely healed wound
• within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
• Prior treatment with ingenol mebutate gel on the treatment area
• Lesions in the treatment areas that have:
• atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
• recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Where it is running

• Omni Dermatology — Phoenix, Arizona, United States
• Torrance Clinical Research Institute Inc. — Lomita, California, United States
• Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. — San Diego, California, United States
• Dermatology Associates and Research — Coral Gables, Florida, United States
• Leavitt Medical Associates of Florida — Ormond Beach, Florida, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Hudson Dermatology, LLC — Evansville, Indiana, United States
• Indiana Clinical Trials Center — Plainfield, Indiana, United States
• DermAssociates, PC — Rockville, Maryland, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• The Dermatology Group, P.C. — Verona, New Jersey, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Pflugerville Dermatology Clinical Research Center, Inc. — Pflugerville, Texas, United States
• Kirk Barber Research — Calgary, Alberta, Canada
• Enverus Medical — Surrey, British Columbia, Canada
• Skin Care Centre — Vancouver, British Columbia, Canada
• Winnipeg Clinic Dermatology Research — Winnipeg, Manitoba, Canada
• UltraNova Skincare — Barrie, Ontario, Canada
• Dermatrials Research Incorporated — Hamilton, Ontario, Canada
• The Guenther Dermatology Research Centre — London, Ontario, Canada
• SKiN Centre for Dermatology — Peterborough, Ontario, Canada

Full record on ClinicalTrials.gov

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