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

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120456
• Other study ID #: LP0084-1015
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• LEO 43204

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])	Complete clearance was defined as a 100% reduction from baseline in AK count.	From baseline to Week 8
Secondary	Part 2: Participants With Partial Clearance of AKs (LOCF)	Partial clearance was defined as at least 75% reduction from baseline in AK count.	From baseline to Week 8

External Links

•   Clinical Trials at LEO Pharma