Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

LEO Pharma220 enrolled

Overview

To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate 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

220

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 full balding scalp. * Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp 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 (1)

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, United States

Outcomes

Primary Outcomes

Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)

The number participants experiencing a DLT was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT. A DLT was defined as: * Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale * Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT. The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are 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) Lesion Count

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

Time frame: From baseline to Week 8

Secondary Outcomes

Part 2: Participants With Complete Clearance of AKs

Complete clearance of AKs at Week 8 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

Partial clearance of AKs at Week 8 was defined as at least 75% reduction from baseline in AK count.

Time frame: From baseline to Week 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.