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Completed

NCT Number: NCT02305888

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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Long Island Skin Cancer and Dermatologic Surgery

Smithtown, New York, 11787, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

LEO 43204

Drug

Treatment of actinic keratosis

Primary outcomes

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

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

    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

Secondary outcomes

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

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

    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.

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

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

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

  3. Percentage of Participants With Complete Clearance of AKs

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2014
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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