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

Phase 2CompletedNCT02120456

LEO Pharma224 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

224

Conditions

Actinic Keratosis

Interventions

LEO 43204DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (21)

Omni Dermatology

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From baseline to Week 8

Secondary Outcomes

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.

Time frame: From baseline to Week 8

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

Partial clearance was defined as at least 75% reduction from baseline in AK count.

Time frame: From baseline to Week 8

Data from ClinicalTrials.gov

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