Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

LEO Pharma437 enrolled

Overview

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

437

Conditions

Actinic Keratosis

Interventions

LEO 43204 gelDRUG

Vehicle gelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest * Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area Exclusion Criteria: * Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC * Treatment with ingenol mebutate gel in the treatment area within the last 12 months * Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions) * 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)

Locations (1)

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Outcomes

Primary Outcomes

Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)

Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area. The table shows the percentage of mean number of subjects across imputations with complete clearance.

Time frame: At Week 8

Secondary Outcomes

Percentage of Participants With Partial Clearance (Multiple Imputation)

Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance.

Time frame: At Week 8

Percentage of Participants With Partial Clearance (Multiple Imputation)

Time frame: At Week 4

Percent Reduction in AK Count in the Treatment Area Compared to Baseline

The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.

Time frame: At Week 8

Data from ClinicalTrials.gov

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