This trial is active, not recruiting.

Condition actinic keratosis
Treatment ingenol mebutate
Phase phase 3
Sponsor LEO Pharma
Start date April 2015
End date March 2016
Trial size 730 participants
Trial identifier NCT02361216, LP0105-1032


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Treatment once daily for 3 days
ingenol mebutate
(Placebo Comparator)
Treatment once daily for 3 days
ingenol mebutate

Primary Outcomes

Complete resolution of actinic keratosis (AK)
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official 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
Principal investigator C. William Hanke, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by LEO Pharma.