Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively

LEO Pharma189 enrolled

Overview

The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

189

Conditions

Actinic Keratosis

Interventions

LEO 43204DRUG

Treatment of actinic keratosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either: * The full face * The full balding scalp * A contiguous area of approximately 250 cm2 on trunk or extremities Exclusion Criteria: Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme. Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Locations (1)

Long Island Skin Cancer and Dermatologic Surgery

Smithtown, New York, United States

Outcomes

Primary Outcomes

Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)

For face/chest, 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: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities 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 four LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3

Time frame: 8 days / From baseline (Day 1) to Day 8

Secondary Outcomes

Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic

The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.

Time frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8

Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic

Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.

Time frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8

Percentage of Participants With Complete Clearance of AKs

Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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