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

NCT02120456 | Completed Phase 1 Results

• 1 other identifier: LP0084-1015
• Study Type: interventional
• Target: 224
• Locations: 2 countries
• Sites: 21

Brief Summary

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

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (2)

• Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)

  The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT. A DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 or two or more of the following five LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT. The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.

  From Day 1 up to and including Day 8

• Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count

  Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.

  From baseline to Week 8

Secondary Outcomes (2)

• Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])

  From baseline to Week 8

• Part 2: Participants With Partial Clearance of AKs (LOCF)

  From baseline to Week 8

Study Arms (4)

LEO 43204

EXPERIMENTAL

Open-label, dose-escalation, 2-day treatment

Drug: LEO 43204

LEO 43204 Dose 0.1%

EXPERIMENTAL

LEO 43204 dose 0.1% once daily for two consecutive days

Drug: LEO 43204

LEO 43204 Dose 0.075%

EXPERIMENTAL

LEO 43204 dose 0.075% once daily for two days

Drug: LEO 43204

Placebo

PLACEBO COMPARATOR

Placebo once daily for two days

Drug: Placebo

Interventions

LEO 43204 DRUG

LEO 43204; LEO 43204 Dose 0.075%; LEO 43204 Dose 0.1%

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (21)

Omni Dermatology

Phoenix, Arizona, 85018, United States

Location

Torrance Clinical Research Institute Inc.

Lomita, California, 90717, United States

Location

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California, 92121, United States

Location

Dermatology Associates and Research

Coral Gables, Florida, 33134, United States

Location

Leavitt Medical Associates of Florida

Ormond Beach, Florida, 32174, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47713, United States

Location

Hudson Dermatology, LLC

Evansville, Indiana, 47714, United States

Location

Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

DermAssociates, PC

Rockville, Maryland, 20850, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

The Dermatology Group, P.C.

Verona, New Jersey, 07044, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Pflugerville Dermatology Clinical Research Center, Inc.

Pflugerville, Texas, 78660, United States

Location

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Enverus Medical

Surrey, British Columbia, V3R 6A7, Canada

Location

Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2, Canada

Location

UltraNova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Dermatrials Research Incorporated

Hamilton, Ontario, L8N 1V6, Canada

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 1Z2, Canada

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

LEO 43204

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure Specialist
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

Study Officials

• Gary Goldenberg, MD

  Mount Sinai School of Medicine, Dermatology Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 22, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 6, 2025
• Results First Posted: January 4, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8); US (13)