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

NCT ID: NCT01922050

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-11-30

Brief Summary

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

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1: LEO 43204 Formulation 1

Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment

Group Type: EXPERIMENTAL

LEO 43204 Formulation 1

Intervention Type: DRUG

Part 1: LEO 43204 Formulation 2

Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment

Group Type: EXPERIMENTAL

LEO 43204 Formulation 2

Intervention Type: DRUG

Part 2: LEO 43204 Formulation 1 Dose X

Double-Blind, Once-Daily, 2-Day Treatment

Group Type: EXPERIMENTAL

LEO 43204 Formulation 1 Dose X

Intervention Type: DRUG

Part 2: LEO 43204 Formulation 1 Dose Y

Double-Blind, Once-Daily, 2-Day Treatment

Group Type: EXPERIMENTAL

LEO 43204 Formulation 1 Dose Y

Intervention Type: DRUG

Part 2: LEO 43204 Formulation 2 Dose XX

Double-Blind, Once-Daily, 2-Day Treatment

Group Type: EXPERIMENTAL

LEO 43204 Formulation 2 Dose XX

Intervention Type: DRUG

Part 2: LEO 43204 Formulation 2 Dose YY

Double-Blind, Once-Daily, 2-Day Treatment

Group Type: EXPERIMENTAL

LEO 43204 Formulation 2 Dose YY

Intervention Type: DRUG

Part 2: Placebo Formulation 1

Double-Blind, Once-Daily, 2-Day Treatment

Group Type: PLACEBO_COMPARATOR

Placebo Formulation 1

Intervention Type: DRUG

Part 2: Placebo Formulation 2

Double-Blind, Once-Daily, 2-Day Treatment

Group Type: PLACEBO_COMPARATOR

Placebo Formulation 2

Intervention Type: DRUG

Interventions

LEO 43204 Formulation 1

Intervention Type: DRUG

LEO 43204 Formulation 2

Intervention Type: DRUG

LEO 43204 Formulation 1 Dose X

Intervention Type: DRUG

LEO 43204 Formulation 1 Dose Y

Intervention Type: DRUG

LEO 43204 Formulation 2 Dose XX

Intervention Type: DRUG

LEO 43204 Formulation 2 Dose YY

Intervention Type: DRUG

Placebo Formulation 1

Intervention Type: DRUG

Placebo Formulation 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face

3. 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

4. Subject at least 18 years of age.

5. Female subjects must be of either:

1. 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,

2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment.

6. Female subjects of childbearing potential must use effective contraception throughout the study.

Exclusion Criteria

1. Location of the treatment area within 5 cm (2 inches) of:

1. an incompletely healed wound,

2. a suspected basal or squamous cell carcinoma.

2. Prior treatment with ingenol mebutate gel on the treatment area.

3. Lesions in the treatment areas that have:

1. atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or

2. recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

4. 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.

5. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.

6. 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.

7. 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.

8. 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.

9. Known sensitivity or allergy to any of the ingredients in the LEO 43204.

10. Presence of acute sunburn within the treatment areas.

11. Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.

12. Subjects previously randomised in the trial (Part 1 or 2).

13. Female subjects who are breastfeeding.

14. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Goldenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai School of Medicine, Dermatology Faculty

Locations

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

Countries

United States; Canada

References

Bourcier M, Stein Gold L, Guenther L, Andreassen CM, Selmer J, Goldenberg G. A dose-finding trial with a novel ingenol derivative (ingenol disoxate: LEO 43204) for field treatment of actinic keratosis on full face or 250 cm2 on the chest. J Dermatolog Treat. 2017 Nov;28(7):652-658. doi: 10.1080/09546634.2017.1303568. Epub 2017 Apr 4.

Reference Type: DERIVED

PMID: 28264612 (View on PubMed)

Other Identifiers

LP0084-1013

Identifier Type: -

Identifier Source: org_study_id