A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients 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 two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Key facts

Study ID

NCT01922050

Run by

LEO Pharma

People needed

320

Starts

2013-10-01

Expected to finish

2014-11-01

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…

• Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures.
• Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face
• Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face or within a contiguous area of approximately 250 cm2 (40 in2) on the chest
• Subject at least 18 years of age.
• Female subjects must be of either:
• Non-childbearing potential, i.e., have a confirmed clinical history of sterility (e.g., the subject is without a uterus or have tubal ligation), or,
• Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment.
• Female subjects of childbearing potential must use effective contraception throughout the study.

You may not qualify if…

• Location of the treatment area within 5 cm (2 inches) of:
• an incompletely healed wound,
• a suspected basal or squamous cell carcinoma.
• 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).
• History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum, Rosacea), at the investigator's discretion.
• Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
• Any other disease or medical condition such as history or presence of cancer, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, or neurological disease or disorder, that, in the opinion of the investigator, makes the subject unsuitable to participate in the trial.
• Any abnormal laboratory or ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
• Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications.
• Known sensitivity or allergy to any of the ingredients in the LEO 43204.
• Presence of acute sunburn within the treatment areas.
• Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
• Subjects previously randomised in the trial (Part 1 or 2).
• Female subjects who are breastfeeding.
• In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state).

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
• Leavitt Medical Associates of Florida — Ormond Beach, Florida, United States
• Clinical Research Center, Morsani Center for Advanced Healthcare — Tampa, Florida, United States
• Research Institute of Deaconess Clinic — Evansville, Indiana, United States
• Hudson Dermatology, LLC — Evansville, Indiana, United States
• DermAssociates, PC — Rockville, Maryland, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Henry Ford Medical Center, Dept. of Dermatology — West Bloomfield, Michigan, United States
• The Dermatology Group, P.C. — Verona, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Stratica Medical Inc. — Edmonton, Alberta, Canada
• Guildford Dermatology Specialists — Surrey, British Columbia, Canada
• Durondel C.P. Inc./Dermatology Clinic — Moncton, New Brunswick, Canada
• Ultranova Skincare — Barrie, Ontario, Canada
• Co-Medica Research Network Inc. — Courtice, Ontario, Canada
• Dermatrials Research Incorporated — Hamilton, Ontario, Canada
• The Guenther Dermatology Research Centre — London, Ontario, Canada
• Lynderm Research Inc. — Markham, Ontario, Canada
• SKiN Centre for Dermatology — Peterborough, Ontario, Canada
• K. Papp Clinical Research — Waterloo, Ontario, Canada
• XLR8 Medical Research — Windsor, Ontario, Canada
• Centre de Recherche Dermatologique du Quebec Metropolitain — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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