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OpenTrials
Completed

NCT Number: NCT02361216

Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

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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

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic 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 the chest

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 squamous cell carcinoma (SCC).
  • Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
  • 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 horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Treatment and study plan

Ingenol Mebutate

Drug

Vehicle

Other

Vehicle gel

Primary outcomes

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

    Time frame: 8 weeks

    Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs

Secondary outcomes

  1. Percentage of Participants With Partial Clearance at Week 8

    Time frame: 8 weeks

    Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.

  2. Percentage of Participants With Partial Clearance at Week 4

    Time frame: 4 weeks

    Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.

  3. Percent Reduction From Baseline in AK Count

    Time frame: 8 weeks

    Percent reduction in AK count in the selected treatment area at Week 8

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 11, 2015
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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