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Completed

NCT Number: NCT02549352

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

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

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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 3

Primary location

Klinik für Dermatologie & Allergologie Klinikum Vest GmbH

Recklinghausen, 45657, Germany

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 AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
  • 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 (balding scalp) 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)

Treatment and study plan

LEO43204 gel

Drug

Other names: Ingenol Disoxate

Vehicle gel

Drug

Primary outcomes

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

    Time frame: At Week 8

    The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8.

    Complete clearance was defined as no clinically visible AKs in the treatment area.

    The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.

Secondary outcomes

  1. Percentage of Participants With Partial Clearance

    Time frame: At Week 8

    The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.

    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 at Week 8.

  2. Percentage of Participants With Partial Clearance

    Time frame: At Week 4

    The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.

    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 at Week 4.

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

    Time frame: At Week 8

    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.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 15, 2015
Registry last updated
Mar 13, 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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