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Completed

NCT Number: NCT02100813

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

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

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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 1 / Phase 2

Primary location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

LEO 43204

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: From Day 1 up to and including Day 8

    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.

  2. Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count

    Time frame: From baseline to Week 8

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

Secondary outcomes

  1. Part 2: Participants With Complete Clearance of AKs

    Time frame: From baseline to Week 8

    Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.

  2. Part 2: Participants With Partial Clearance of AKs

    Time frame: From baseline to Week 8

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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 1, 2014
Registry last updated
Mar 6, 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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